Drugs / Olaparib
Olaparib
also known as
AZD2281 · Lynparza · KU-0059436 · AZD2281 (Olaparib) · AZ-2281 · KU-59436 · NSC-747856 · Olaparaib · +5 more
Small molecule targets PARP1, PARP2, PARP3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 25 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed castration-resistant prostate carcinoma 2 milestones | |||||
| Filed | US (FDA) | Lynparza | castration-resistant prostate carcinoma | 2022-08-16 | “accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).” merck.com ↗ “supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted” astrazeneca.com ↗ “a supplemental New Drug Application (sNDA) for LYNPARZA in combination with abiraterone and prednisone or prednisolone has been accepted” merck.com ↗ |
| Filed | US (FDA) | Lynparza | castration-resistant prostate carcinoma | 2020-01-20 | “a supplemental New Drug Application (sNDA) for LYNPARZA has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA)” merck.com ↗ “In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial” astrazeneca.com ↗ “sNDA for Lynparza in combination with abiraterone and prednisone or prednisolone was accepted and granted Priority Review in the US” astrazeneca.com ↗ “In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review” merck.com ↗ “a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review in the US” astrazeneca.com ↗ |
| Filed female breast nipple and areola cancer 2 milestones | |||||
| Filed | US (FDA) | Lynparza | female breast nipple and areola cancer | 2021-11-30 | “a supplemental New Drug Application (sNDA) for LYNPARZA has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA)” merck.com ↗ “AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) has been accepted” astrazeneca.com ↗ |
| Filed | Japan (PMDA) | Lynparza | female breast nipple and areola cancer | 2017-10-23 | “(NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of LYNPARZA ® (olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer” astrazeneca.com ↗ |
| Filed metastatic squamous cell carcinoma 1 milestone | |||||
| Filed | EU (EMA) | Lynparza | metastatic squamous cell carcinoma | 2018-04-03 | “today announced that the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for LYNPARZA ® (olaparib)” merck.com ↗ “today announced that the European Medicines Agency has validated for review the Marketing Authorisation Application (MAA) for Lynparza (olaparib)” astrazeneca.com ↗ |
| Filed ovarian carcinoma 2 milestones | |||||
| Filed | US (FDA) | Lynparza | ovarian carcinoma | 2020-01-13 | “a supplemental New Drug Application for Lynparza (olaparib) in combination with bevacizumab has been accepted and granted Priority Review in the US” astrazeneca.com ↗ “AstraZeneca filed the US regulatory submission for olaparib in February 2014.” astrazeneca.com ↗ |
| Filed | EU (EMA) | — | ovarian carcinoma | 2013-09-27 | “AstraZeneca today announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application (MAA) for olaparib” astrazeneca.com ↗ “The EMA accepted a marketing authorisation application for olaparib in September 2013.” astrazeneca.com ↗ |
| Filed pancreatic ductal adenocarcinoma 2 milestones | |||||
| Filed | EU (EMA) | Lynparza | pancreatic ductal adenocarcinoma | 2019-10-29 | “Merck and AstraZeneca received filing submission acceptances from the FDA and EMA for the use of Lynparza in BRCA m pancreatic cancer.” merck.com ↗ |
| Filed | US (FDA) | Lynparza | pancreatic ductal adenocarcinoma | 2019-10-29 | “Merck and AstraZeneca received filing submission acceptances from the FDA and EMA for the use of Lynparza in BRCA m pancreatic cancer.” merck.com ↗ |
| Filed stage I endometrioid carcinoma 1 milestone | |||||
| Filed | Japan (PMDA) | Lynparza | stage I endometrioid carcinoma | — | “Regulatory submissions for Imfinzi and Lynparza are currently under review in Japan” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (13) | US (FDA) | LYNPARZA | — | 2017-08-17 – 2023-11-06 | fda.gov ↗ |
| Approved | US (FDA) | LYNPARZA | — | 2014-12-19 | fda.gov ↗ |
| Approved | EU (EMA) | Lynparza | — | 2014-12-16 | europa.eu ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 010 trials | ||||||
| Phase 0 | NCT05432518 | Jun 2023 → Jul 2027 expected | adult glioblastoma | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 0 | NCT05320757 | Apr 2022 → May 2025 | endometrial cancer | The University of Hong Kong | Completed | No outcome recorded |
| Phase 0 | NCT04614909 | Jan 2021 → Jul 2023 | adult glioblastoma | Nader Sanai | Completed | No outcome recorded |
| Phase 0 | NCT04005690 | Aug 2019 → Jun 2027 expected | pancreatic ductal adenocarcinoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 0 | NCT04041128 | Jul 2019 → Jun 2021 | breast cancer, ovarian cancer | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 0 | NCT03943173 | Jun 2019 → Jun 2027 expected | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, fallopian tube serous adenocarcinoma, ovarian serous adenocarcinoma +1 | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 0 | NCT03251872 | Oct 2018 → Dec 2019 | pulmonary arterial hypertension | Laval University | Terminated | No outcome recorded |
| Phase 0 | NCT03378297 | May 2018 → Jan 2023 | ovarian cancer | Haukeland University Hospital | Completed | No outcome recorded |
| Phase 0 | NCT02855697 | May 2017 → Dec 2021 | ovarian cancer | The Christie NHS Foundation Trust | Completed | No outcome recorded |
| Phase 196 trials · 1 met primary | ||||||
| Phase 1 | NCT07382544 | Feb 2026 → Jan 2030 expected | cancer of unknown primary site | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06856499 | Dec 2025 → Jul 2027 expected | fallopian tube cancer, ovarian endometrial cancer, primary peritoneal carcinoma | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 1 | NCT07090369 | Nov 2025 → Dec 2028 expected | castration-resistant prostate carcinoma | Peter MacCallum Cancer Centre, Australia | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07156253 | Aug 2025 → Aug 2028 expected | breast cancer, metastatic neoplasm, ovarian cancer | Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT06976892 | Aug 2025 → Dec 2029 expected | malignant ovarian serous tumor | Institute of Cancer Research, United Kingdom | Recruiting | No outcome recorded |
| Phase 1 | NCT06686745 | Dec 2024 → Jun 2027 expected | cancer | Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06560632 | Sep 2024 → Oct 2025 | neoplasm | Repare Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT06545942 | Aug 2024 → May 2027 expected | breast cancer, metastatic neoplasm, ovarian cancer, pancreatic neoplasm +1 | MOMA Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05900895 | Jul 2024 → Dec 2027 expected | breast cancer | Mary D Chamberlin | Recruiting | No outcome recorded |
| Phase 1 | NCT05932862 | Apr 2024 → Jan 2029 expected | neoplasm | Exelixis | Recruiting | No outcome recorded |
| Phase 1 | NCT06331559 | Mar 2024 → Sep 2025 | cancer | Jiangsu Simcere Pharmaceutical Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05807126 | Mar 2024 → Dec 2026 | castration-resistant prostate carcinoma, female breast carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT06177171 | Feb 2024 → Jan 2028 expected | ATM-related cancer predisposition, BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, CHEK2-related cancer predisposition +1 | Varun Monga, MBBS | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06130254 | Jan → Jun 2024 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT05411094 | May 2023 → Aug 2026 overdue | digestive system carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05774886 | May → Sep 2023 | female breast carcinoma, triple-negative breast carcinoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT05358639 | Nov 2022 → Mar 2025 overdue | ovarian serous adenocarcinoma, triple-negative breast carcinoma | Sunnybrook Health Sciences Centre | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05238922 | Jul 2022 → Jul 2027 expected | cancer | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05870423 | Jun 2022 → Jan 2027 expected | neuroendocrine neoplasm | Erasmus Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05252390 | Mar 2022 → Jul 2024 | malignant pancreatic neoplasm, ovarian carcinoma, prostate carcinoma, triple-negative breast carcinoma | Nuvation Bio Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT04633239 | Jul 2021 → Nov 2026 expected | ovarian serous adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT04585958 | May 2021 → Dec 2026 expected | metastatic malignant neoplasm, ovarian serous cystadenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT04550104 | Mar 2021 → Mar 2026 overdue | non-small cell lung carcinoma | University of Leeds | Recruiting | No outcome recorded |
| Phase 1 | NCT03685331 | Oct 2020 → Aug 2025 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, breast cancer | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT03924245 | Oct 2020 → Feb 2022 | fallopian tube carcinosarcoma, fallopian tube clear cell adenocarcinoma, fallopian tube endometrioid adenocarcinoma, fallopian tube serous adenocarcinoma +5 | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT04197713 | Jun 2020 → Feb 2023 overdue | metastatic malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04399876 | Jun 2020 → Aug 2027 expected | prostate cancer | Brigham and Women's Hospital | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT04375267 | Apr 2020 → Jun 2024 | mesothelioma, neuroendocrine neoplasm, thymoma | Vastra Gotaland Region | Completed | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04236414 | Jan 2020 → Feb 2025 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03842228 | Nov 2019 → Jul 2024 overdue | metastatic malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03259503 | Sep 2019 → Nov 2025 | Hodgkins lymphoma, T-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03874884 | Jul 2019 → May 2025 overdue | prostate carcinoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03742245 | Jun 2019 → Dec 2025 overdue | breast carcinoma | The Methodist Hospital Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03923270 | Jun 2019 → Jun 2023 overdue | small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03955640 | May 2019 → Aug 2021 | breast carcinoma, malignant neoplasm of chest wall | Thomas Jefferson University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03772561 | Dec 2018 → Dec 2026 expected | cancer | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 1 | NCT03641755 | Oct 2018 → Apr 2022 overdue | breast cancer | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03532880 | Jul 2018 → Feb 2025 | small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03553108 | May 2018 → Mar 2019 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03544125 | May → Aug 2018 | female breast carcinoma, triple-negative breast carcinoma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02686008 | Jan 2018 → Jan 2019 | head and neck squamous cell carcinoma | Yale University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03022409 | Sep 2017 → Jan 2021 | head and neck squamous cell carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03162627 | Aug 2017 → Aug 2026 overdue | breast cancer, digestive system cancer, female reproductive organ cancer, male reproductive organ cancer +1 | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03109080 | Jul 2017 → Feb 2020 | female breast carcinoma, triple-negative breast carcinoma | Institut Curie | Completed | No outcome recorded |
| Phase 1 | NCT03205176 | Jun 2017 → Mar 2021 | breast cancer, lymphoma, malignant pancreatic neoplasm, ovarian cancer +1 | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02898207 | May 2017 → Jul 2020 | fallopian tube serous adenocarcinoma, high grade malignant neoplasm, metastatic malignant neoplasm, ovarian serous adenocarcinoma +2 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT03057145 | Mar 2017 → Feb 2020 | cancer | Geoffrey Shapiro, MD, PhD | Completed | No outcome recorded |
| Phase 1 | NCT02546661 | Dec 2016 → Mar 2020 overdue | infiltrating bladder urothelial carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02324998 | Dec 2016 → May 2019 | prostate cancer | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT02485990 | Jan 2016 → Mar 2020 | primary peritoneal carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 1 | NCT02787642 | Jan 2016 → Oct 2021 | soft tissue sarcoma | Institut Bergonié | Completed | No outcome recorded |
| Phase 1 | NCT02561832 | Nov 2015 → Sep 2016 | breast cancer | AstraZeneca | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02308072 | Sep 2015 → Jun 2020 | head and neck cancer | University College, London | Completed | No outcome recorded |
| Phase 1 | NCT02511795 | Aug 2015 → Apr 2019 | refractory malignant neoplasm, small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02430311 | Jun 2015 → Jul 2016 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02418624 | May 2015 → Jan 2019 | breast cancer, ovarian cancer | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02208375 | Nov 2014 → Jun 2028 expected | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, endometrium adenocarcinoma, fallopian tube carcinoma +4 | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02264678 | Oct 2014 → Mar 2025 overdue | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02229656 | Sep 2014 → Jan 2020 | head and neck neoplasm, larynx cancer, squamous cell carcinoma | The Netherlands Cancer Institute | Unknown | No outcome recorded |
| Phase 1 | NCT02093351 | Sep 2014 → Apr 2015 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02398058 | Jul 2014 → Dec 2019 | bone neoplasm, soft tissue sarcoma | Italian Sarcoma Group | Completed | No outcome recorded |
| Phase 1 | NCT02121990 | Apr 2014 → Aug 2020 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02338622 | Mar 2014 → Mar 2016 | cancer of unknown primary site | Royal Marsden NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT01894243 | Mar 2014 → Nov 2016 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01929603 | Dec 2013 → May 2014 | cancer | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01894256 | Nov 2013 → Mar 2015 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02227082 | Oct 2013 → Sep 2019 | inflammatory breast carcinoma, triple-negative breast carcinoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01900028 | Oct 2013 → Apr 2014 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01921140 | Sep 2013 → Apr 2014 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01851265 | Jul → Oct 2013 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01858168 | Jul 2013 → Nov 2024 | Ewing sarcoma, rhabdomyosarcoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01460888 | Jul 2013 → Jul 2015 | carcinoma of esophagus | The Christie NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 1 | NCT01813474 | Mar 2013 → Aug 2016 | high grade malignant neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01758731 | Oct 2012 → Dec 2016 | head and neck squamous cell carcinoma | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT01623349 | Sep 2012 → May 2019 | breast cancer, ovarian cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01562210 | Apr 2012 → May 2019 | non-small cell lung carcinoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01390571 | Jul 2011 → Jun 2017 | central nervous system neoplasm | Cancer Research UK | Completed | No outcome recorded |
| Phase 1 | NCT01237067 | Feb 2011 → Nov 2014 | breast cancer, endometrial cancer, fallopian tube cancer, ovarian cancer +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01296763 | Jan 2011 → Jan 2014 | malignant pancreatic neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1 | NCT00819221 | Jan 2009 → Nov 2011 | cancer | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT00782574 | Nov 2008 → Feb 2012 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00777582 | Oct 2008 → Feb 2009 overdue | cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT00707707 | Sep 2008 → Nov 2009 | triple-negative breast carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00710268 | Jun 2008 → Mar 2009 | metastatic neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01445418 | May 2008 → Sep 2014 | breast cancer, ovarian cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00678132 | Apr 2008 → Nov 2010 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00633269 | Apr → Oct 2008 | metastatic neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00535353 | Jan 2008 → Sep 2012 | colorectal cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 1 | NCT00572364 | Nov 2007 → Mar 2009 | high grade malignant neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00515866 | Aug 2007 → Oct 2011 | pancreatic neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00516438 | Jul 2007 → Mar 2009 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00516724 | Jun 2007 → Jan 2013 | ovarian cancer, triple-negative breast carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00516802 | Jan 2007 → Jan 2009 | melanoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00516373 | Jul 2005 → Dec 2008 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, ovarian cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01491139 | — | squamous cell carcinoma | University College, London | Withdrawn | No outcome recorded |
| Phase 1/239 trials · 2 met primary · 1 missed | ||||||
| Phase 1/2 | NCT07850973 | Mar 2027 → Dec 2029 expected | malignant germ cell tumor | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07453394 | Apr 2026 → Apr 2027 expected | endometrial cancer, gastric cancer, non-small cell lung carcinoma, ovarian cancer | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07460180 | May 2025 → May 2027 expected | epithelial neoplasm, fallopian tube cancer, ovarian cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06607692 | Sep 2024 → Jul 2029 expected | adrenal carcinoma, diffuse intrinsic pontine glioma, ependymoma, esthesioneuroblastoma +10 | HM Hospitales | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06525298 | Sep 2024 → Sep 2027 expected | neoplasm | Eisbach Bio GmbH | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06353386 | May 2024 → Jan 2029 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06217757 | Apr 2024 → Oct 2027 expected | small cell lung carcinoma | Sichuan University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06298084 | Mar 2024 → Sep 2027 expected | HER2 positive breast carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06065059 | Dec 2023 → May 2024 | BRCA1-related cancer predisposition, hereditary breast carcinoma, malignant pancreatic neoplasm, ovarian carcinoma +1 | Tango Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT05975944 | Sep 2023 | small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT05898399 | Jun 2023 → Jun 2028 expected | metastatic neoplasm, neoplasm | Artios Pharma Ltd | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05933265 | Jun 2023 → Jul 2026 overdue | glioblastoma, metastatic neoplasm, non-small cell lung carcinoma, pancreatic adenocarcinoma +1 | Lantern Pharma Inc. | Active not recruiting | Met primary |
| Phase 1/2 | NCT05700669 | Feb → Oct 2023 | breast cancer, malignant epithelial tumor of ovary, prostate carcinoma | Valerio Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT04086485 | Oct 2022 → Jul 2027 expected | digestive system neuroendocrine neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05405309 | Sep 2022 → Oct 2023 | chronic lymphocytic leukemia/small lymphocytic lymphoma | University of Utah | Terminated | No outcome recorded |
| Phase 1/2 | NCT04711824 | Mar 2022 → Jul 2026 overdue | breast cancer, metastatic malignant neoplasm in the brain | Colette Shen | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04592211 | Oct 2021 → Dec 2025 overdue | gastric cancer | Yonsei University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04972110 | Jul 2021 → Nov 2024 | — | Repare Therapeutics | Terminated | No outcome recorded |
| Phase 1/2 | NCT04728230 | Jan 2021 → Dec 2027 expected | small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04410887 | Dec 2020 → Dec 2021 | gastric cancer | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03782818 | Nov 2019 → Oct 2024 | pulmonary arterial hypertension | Laval University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03317392 | Feb 2019 → Mar 2025 overdue | castration-resistant prostate carcinoma, prostate adenocarcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03568656 | Jul 2018 → Jul 2025 | breast cancer, castration-resistant prostate carcinoma, non-small cell lung carcinoma | CellCentric Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT03594396 | Jun 2018 → Dec 2025 overdue | breast neoplasm | Seoul National University Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03008278 | Feb 2018 → Jun 2023 | carcinoma of esophagus, gastric carcinoma, gastroesophageal junction adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT03212742 | Sep 2017 → Sep 2026 overdue | malignant glioma | Centre Francois Baclesse | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03085147 | Mar 2017 → Jul 2026 overdue | oral cavity squamous cell carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02861573 | Nov 2016 → Oct 2027 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02755844 | Sep 2016 → Nov 2018 | endometrial cancer | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 1/2 | NCT02813135 | Aug 2016 → Feb 2031 expected | childhood malignant neoplasm | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02769962 | May 2016 → Apr 2023 | prostate cancer, small cell lung carcinoma, urothelial carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT02734004 | Mar 2016 → Sep 2021 overdue | breast disorder, gastric cancer, ovarian disorder, small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02571725 | Feb 2016 → Dec 2020 overdue | fallopian tube cancer, ovarian cancer, peritoneal neoplasm | New Mexico Cancer Research Alliance | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02446704 | Oct 2015 → Dec 2022 | small cell lung carcinoma | Zofia Piotrowska | Unknown | No outcome recorded |
| Phase 1/2 | NCT02684318 | Jul 2015 → Jul 2019 | breast cancer, cancer of unknown primary site, endometrial cancer, ovarian cancer | Poveda, Andrés, M.D. | Unknown | No outcome recorded |
| Phase 1/2 | NCT02484404 | Jun 2015 → Oct 2027 expected | breast cancer, colorectal cancer | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01650376 | Aug 2012 → Dec 2018 | ovarian carcinoma, uterine cancer | Swedish Medical Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT01513174 | Aug 2011 → Jul 2016 | non-small cell lung carcinoma | Spanish Lung Cancer Group | Completed | Missed primary |
| Phase 1/2 | NCT01116648 | Apr 2010 → Oct 2018 overdue | fallopian tube carcinoma, ovarian endometrioid adenocarcinoma, ovarian serous surface papillary adenocarcinoma, primary peritoneal serous adenocarcinoma +1 | National Cancer Institute (NCI) | Active not recruiting | Met primary |
| Phase 2213 trials · 7 met primary · 13 missed | ||||||
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05522491 | Sep 2026 → Sep 2030 expected | neoplasm | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07647653 | Jun 2026 → Feb 2031 expected | ovarian cancer | Shandong University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07667751 | Jun 2026 → Dec 2027 expected | ovarian cancer | Bai-Rong Xia | Recruiting | No outcome recorded |
| Phase 2 | NCT05128734 | Apr 2026 → Apr 2028 expected | triple-negative breast carcinoma | AHS Cancer Control Alberta | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07407452 | Feb 2026 → Dec 2027 expected | ovarian cancer | Jiangsu Cancer Institute & Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07113964 | Aug 2025 → Mar 2027 expected | Her2-receptor negative breast cancer | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07024784 | Jul 2025 → Jan 2028 expected | fallopian tube cancer, primary peritoneal carcinoma | AbbVie | Recruiting | No outcome recorded |
| Phase 2 | NCT07005583 | Jun 2025 → May 2027 expected | triple-negative breast carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05093231 | Feb 2025 → Jul 2027 expected | pancreatic adenocarcinoma | Cambridge University Hospitals NHS Foundation Trust | Recruiting | No outcome recorded |
| Show all 213 trials opens the full record — a long page | ||||||
| Phase 2/34 trials · 2 missed | ||||||
| Phase 2/3 | NCT07641855 | Jun 2026 → Dec 2028 expected | castration-resistant prostate carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05432791 | Mar 2023 → Aug 2024 overdue | leiomyosarcoma of the corpus uteri | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT02502266 | May 2016 → Jun 2023 overdue | fallopian tube clear cell adenocarcinoma, fallopian tube endometrioid adenocarcinoma, fallopian tube serous adenocarcinoma, fallopian tube transitional cell carcinoma +7 | National Cancer Institute (NCI) | Active not recruiting | Missed primary |
| Phase 2/3 | NCT03150576 | May 2016 → Jun 2024 overdue | breast cancer | Cambridge University Hospitals NHS Foundation Trust | Recruiting | Missed primary |
| Phase 336 trials · 12 met primary · 7 missed | ||||||
| Phase 3 | NCT06580314 | Mar 2025 → Dec 2034 expected | fallopian tube endometrioid adenocarcinoma, fallopian tube serous adenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian serous adenocarcinoma +1 | NRG Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT06746116 | Dec 2024 → Nov 2028 expected | endometrial cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06712472 | Jun 2024 → Jun 2030 expected | endometrial cancer | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05255471 | Jan 2022 → Jan 2028 expected | ovarian cancer | National Cancer Institute, Naples | Recruiting | No outcome recorded |
| Phase 3 | NCT04729387 | Jul 2021 → Apr 2023 | ovarian cancer | Novartis Pharmaceuticals | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT05171816 | Jun 2021 → Jan 2024 overdue | prostate carcinoma | AstraZeneca | Active not recruiting | Missed primary |
| Phase 3 | NCT04884360 | May 2021 → Jul 2026 overdue | ovarian carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04624204 | Dec 2020 → Oct 2027 expected | small cell lung carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04456699 | Aug 2020 → Mar 2023 | colorectal cancer | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT04421963 | Aug 2020 → Apr 2027 expected | breast cancer, ovarian cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04380636 | Jul 2020 → May 2027 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04269200 | May 2020 → Jul 2024 overdue | endometrial cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT03976362 | Jun 2019 → Sep 2023 | non-small cell squamous lung carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03976323 | Jun 2019 → Feb 2024 | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT03834519 | May 2019 → Mar 2022 | prostate neoplasm | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT03737643 | Jan 2019 → Mar 2025 overdue | ovarian carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03740165 | Dec 2018 → Aug 2024 | fallopian tube cancer, ovarian cancer, peritoneal neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03732820 | Oct 2018 → Jul 2021 overdue | prostate carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03486873 | Aug 2018 → Aug 2043 expected | cancer, hematopoietic and lymphoid cell neoplasm | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT03278717 | Jun 2018 → Dec 2023 | ovarian cancer | University College, London | Unknown | No outcome recorded |
| Phase 3 | NCT03534453 | May 2018 → Jan 2025 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03402841 | Jan 2018 → Oct 2020 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03286842 | Jan 2018 → Oct 2021 | Her2-receptor negative breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03106987 | Jun 2017 → Feb 2021 | malignant epithelial tumor of ovary | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02987543 | Feb 2017 → Jun 2019 | prostate carcinoma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02392676 | Jul 2016 → Jun 2019 | — | AstraZeneca | Withdrawn | No outcome recorded |
| Phase 3 | NCT02446600 | Mar 2016 → Feb 2020 overdue | fallopian tube clear cell adenocarcinoma, fallopian tube transitional cell carcinoma, ovarian clear cell adenocarcinoma, ovarian endometrioid adenocarcinoma +5 | National Cancer Institute (NCI) | Active not recruiting | Missed primary |
| Phase 3 | NCT02477644 | May 2015 → Mar 2019 | ovarian cancer | Arcagy Research | Completed | Met primary |
| Phase 3 | NCT02282020 | Feb 2015 → Oct 2018 | hereditary neoplastic syndrome | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02184195 | Dec 2014 → Jan 2019 | hereditary breast ovarian cancer syndrome, pancreatic adenocarcinoma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02032823 | Apr 2014 → Mar 2020 overdue | breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT02000622 | Mar 2014 → Dec 2016 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, breast carcinoma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01874353 | Sep 2013 → Sep 2016 overdue | hereditary neoplastic syndrome | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT01924533 | Sep 2013 → Apr 2016 | gastric cancer | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT01844986 | Aug 2013 → May 2018 overdue | hereditary breast ovarian cancer syndrome, ovarian cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 46 trials · 2 missed | ||||||
| Phase 4 | NCT07695259 | May 2026 → Dec 2027 expected | HER2 positive breast carcinoma | Wen-Ming Cao | Recruiting | No outcome recorded |
| Phase 4 | NCT06121401 | Sep 2023 → Mar 2027 expected | malignant epithelial tumor of ovary | Mario Negri Institute for Pharmacological Research | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05457257 | Jul 2022 → Oct 2024 overdue | castration-resistant prostate carcinoma | AstraZeneca | Active not recruiting | Missed primary |
| Phase 4 | NCT05078671 | Dec 2021 → Dec 2025 | cancer | Radboud University Medical Center | Unknown | Missed primary |
| Phase 4 | NCT04330040 | May 2020 → Sep 2022 | breast cancer, ovarian cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02476968 | Sep 2015 → Apr 2020 | neoplastic disease or syndrome | AstraZeneca | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07187674 | Dec 2025 → Jun 2028 expected | triple-negative breast carcinoma | Harbin Medical University | Not yet recruiting | No outcome recorded |
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02681237 | Apr 2016 → Jan 2022 | ovarian cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03063710 | — | hereditary site-specific ovarian cancer syndrome | AstraZeneca | No longer available | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 1 | NCT07652242 Background | Jul 2026 → Feb 2028 expected | triple-negative breast carcinoma | Immunomic Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06488378 Background | Aug 2024 → May 2027 expected | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, Her2-receptor negative breast cancer, PALB2-related cancer predisposition | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT05240898 Background | Aug 2021 → Nov 2025 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03575078 Background | Jun 2018 → May 2019 | lymphoma | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02588105 Background | Nov 2015 → Sep 2019 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02419495 Background | Jun 2015 → Sep 2024 | cutaneous melanoma, fallopian tube carcinoma, metastatic malignant neoplasm, metastatic melanoma +5 | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT04999605 Background | Jun 2021 → Jun 2022 | ovarian carcinoma | Akeso | Terminated | No outcome recorded |
| Phase 1/2 | NCT04826198 Background | Oct 2020 → Apr 2024 | ovarian cancer | Gustave Roussy, Cancer Campus, Grand Paris | Terminated | No outcome recorded |
| Phase 1/2 | NCT04556617 Background | Sep 2020 → May 2022 | castration-resistant prostate carcinoma | Opna Bio LLC | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT07268794 Background | Nov 2025 → Apr 2027 expected | metastatic prostate carcinoma, prostate adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06829199 Background | Mar 2025 → Jan 2029 | triple-negative breast carcinoma | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06797635 Background | Mar 2025 → Dec 2029 expected | breast cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06116578 Comparator | Jan 2025 → Jul 2027 | cancer | Gustave Roussy, Cancer Campus, Grand Paris | Withdrawn | No outcome recorded |
| Phase 2 | NCT06245889 Background | May 2024 → Jun 2029 expected | triple-negative breast carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT06175390 Background | Mar 2024 → Aug 2026 overdue | triple-negative breast carcinoma | Institut Curie | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05200260 Background | Jul 2022 → Jun 2027 expected | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Shanghai Gynecologic Oncology Group | Recruiting | No outcome recorded |
| Phase 2 | NCT04038502 Comparator | Oct 2019 → Aug 2027 expected | prostate carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT03579784 Background | Nov 2018 → Dec 2024 | gastric cancer | Do-Youn Oh | Unknown | No outcome recorded |
| Phase 2 | NCT04487587 Comparator | Oct 2018 → Mar 2025 overdue | cervical cancer | The Clatterbridge Cancer Centre NHS Foundation Trust | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03330847 Comparator | Mar 2018 → Nov 2020 overdue | triple-negative breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03012321 Comparator | Jan 2017 → Oct 2023 overdue | DNA repair disease, castration-resistant prostate carcinoma, metastatic prostate carcinoma | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01972217 Comparator | Apr 2014 → Sep 2017 | prostate carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01788332 Comparator | Jan 2014 → Dec 2018 | non-small cell lung carcinoma | Lisette Nixon | Unknown | No outcome recorded |
| Phase 2 | NCT01661868 Comparator | Aug 2012 | fallopian tube cancer, ovarian cancer, peritoneum cancer | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 3 | NCT07486687 Comparator | Apr 2026 → Apr 2032 expected | female breast carcinoma, triple-negative breast carcinoma | The Netherlands Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06915025 Background | Jul 2025 → Oct 2032 expected | fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Imunon | Recruiting | No outcome recorded |
| Phase 3 | NCT06966700 Background | Jun 2025 → Mar 2033 expected | triple-negative breast carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06112379 Background | Nov 2023 → Nov 2028 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06135714 Background | Nov 2023 → Nov 2029 expected | breast cancer | Tokyo Medical and Dental University | Recruiting | No outcome recorded |
| Phase 3 | NCT02810743 Comparator | Jan 2017 → Jul 2024 overdue | breast cancer | The Netherlands Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05949424 Comparator | May 2024 → Mar 2025 | breast carcinoma, endometrial carcinoma, ovarian carcinoma, renal cell carcinoma +1 | University Medical Center Groningen | Unknown | No outcome recorded |
| — | NCT03079687 Background | — | ovarian cancer | AstraZeneca | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 206
| Date | Issuer | Release |
|---|---|---|
| 2026-07-20 | NATCO Pharma Ltd. | Regulatory NATCO receives Tentative Approval for Olaparib Tablets from the United States Food and Drug Administration (U.S. FDA) natcopharma.co.in ↗
NATCO Pharma Limited received tentative approval from the U.S. FDA for Olaparib, 100 mg, and 150 mg, as bioequivalent to reference listed drug (RLD) Lynparza® tablets of AstraZeneca Pharmaceuticals for the indication in the approved labelling. |
| 2026-07-01 | Alembic Pharmaceuticals Ltd. | Regulatory 18th July, 2026 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that its Partner NATCO Pharma Limited (NATCO) has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olaparib Tablets, 100 mg and 150 mg. |
| 2025-11-07 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Olaparib Tablets, 100 mg and 150 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Olaparib Tablets, 100 mg and 150 mg (USRLD: Lynparza Tablets, 100 mg and 150 mg). |
| 2025-10-17 | Artios Pharma Ltd | Results Artios Announces Phase 1/2a Data for DNA Polymerase Theta Inhibitor ART6043 at ESMO Congress 2025 artios.com ↗
The results highlighted ART6043 in combination with the PARP inhibitor, olaparib, in patients with advanced solid tumors harboring mutations in a DNA damage response pathway. |
| 2025-01-06 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA、第3相KEYLYNK−001試験で主要評価項目である進行上皮性卵巣がん患者さんの無増悪生存期間（PFS）の達成を発表 msd.co.jp ↗
独立データモニタリング委員会が実施した最終解析において、KEYTRUDA®＋LYNPARZA®群では化学療法単独群と比較して、対象患者さんのPFSに統計学的に有意かつ臨床的に意味のある改善が認められました。 |
| 2024-12-11 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Demonstrated Clinically Meaningful Prolonged Survival Benefit in Early Breast Cancer in OlympiA Phase 3 Trial merck.com ↗
87.5% of patients treated with LYNPARZA were alive at six-years vs. 83.2% in the comparator arm |
| 2024-12-11 | AstraZeneca | Results Lynparza demonstrated clinically meaningful prolonged survival benefit in early breast cancer in OlympiA Phase III trial astrazeneca.com ↗
Updated results from the OlympiA Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) at six years for patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer. |
| 2024-12-09 | Merck Sharp & Dohme LLC | Results Merck Announces Phase 3 KEYLYNK-001 Trial Met Primary Endpoint of Progression-Free Survival (PFS) in Patients With Advanced Epithelial Ovarian Cancer merck.com ↗
At the final analysis conducted by an independent Data Monitoring Committee, the KEYTRUDA plus LYNPARZA regimen demonstrated a statistically significant and clinically meaningful improvement in PFS for these patients compared to chemotherapy alone. |
| 2024-08-14 | AstraZeneca | Regulatory Lynparza and Imfinzi combination approved in the EU for patients with mismatch repair proficient advanced or recurrent endometrial cancer astrazeneca.com ↗
AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) have been approved in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer. |
| 2024-07-01 | AstraZeneca | Regulatory Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with mismatch repair proficient advanced or recurrent endometrial cancer astrazeneca.com ↗
AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) have been recommended for approval in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer. |
| 2024-06-17 | AstraZeneca | Results Imfinzi plus chemotherapy approved in the US for mismatch repair deficient advanced or recurrent endometrial cancer astrazeneca.com ↗
The Lynparza (olaparib) and Imfinzi arm, which investigated Imfinzi plus chemotherapy followed by Imfinzi plus Lynparza as maintenance therapy, also met the primary endpoint of progression-free survival (PFS). |
| 2024-04-11 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA 転移性非扁平上皮非小細胞肺がんの特定の患者さんを対象としたKEYTRUDA®（ペムブロリズマブ）＋LYNPARZA®（オラパリブ）維持療法を評価する第3相KEYLYNK−006試験の最新情報を公開 msd.co.jp ↗
KEYLYNK-006試験では、KEYTRUDA ® と化学療法（ペメトレキセド＋カルボプラチンまたはシスプラチン）の併用療法とそれに続くKEYTRUDA ® とLYNPARZA ® の併用療法による維持療法は、KEYTRUDA ® と化学療法（ペメトレキセド＋カルボプラチンまたはシスプラチン）の併用療法とそれに続くKEYTRUDA ® と化学療法（ペメトレキセド）の併用療法による維持療法と比較して、事前に規定されたOSとPFSの統計学的基準に到達しませんでした。 |
| 2024-03-21 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer merck.com ↗
did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) |
| 2024-03-18 | AstraZeneca | Results Lynparza and Imfinzi demonstrated strong clinical benefit and more than doubled median duration of response vs. chemotherapy in patients with mismatch repair proficient advanced or recurrent endometrial cancer astrazeneca.com ↗
In this analysis, median duration of response (DoR) in pMMR patients in the Lynparza and Imfinzi arm was more than double versus the control arm (18.7 months versus 7.6). |
| 2023-12-07 | Merck Sharp & Dohme LLC | Results Merck Announces KEYLYNK-008 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LYNPARZA® (olaparib) for Patients With Metastatic Squamous Non-Small Cell Lung Cancer to Stop for Futility merck.com ↗
Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis (IA3). |
| 2023-10-21 | AstraZeneca | Results Imfinzi plus Lynparza reduced the risk of disease progression or death by 45% vs. chemotherapy in advanced or recurrent endometrial cancer astrazeneca.com ↗
Median PFS was 15.1 months in the Imfinzi plus Lynparza Arm and 9.6 months in the Control Arm. |
| 2023-10-16 | Starpharma Pty Ltd | Results DEP irinotecan IO/PARP combination data presented at AACR starpharma.com ↗
The data show that DEP® irinotecan in combination with an IO agent or a PARP2 inhibitor demonstrated superior anti-tumour activity and significant survival benefit when compared to these agents delivered alone in multiple CRC models. |
| 2023-09-26 | Starpharma Pty Ltd | Results DEP irinotecan combination data presentation starpharma.com ↗
The CRC model used was resistant to olaparib alone, but the combination of DEP ® irinotecan and olaparib achieved increased anti-tumour effects compared to DEP® irinotecan alone, and also prolonged survival. |
| 2023-08-24 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib)Plus Abiraterone and Prednisolone Approved in Japan for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisolone (abi/pred) has been approved in Japan for the treatment of adult patients with BRCA -mutated ( BRCA m) castration-resistant prostate cancer with distant metastasis (mCRPC). |
| 2023-08-24 | AstraZeneca | Regulatory Lynparza plus abiraterone approved in Japan for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisolone has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC). |
| 2023-06-03 | AstraZeneca | Results Lynparza and Imfinzi combination reduced risk of disease progression or death by 37% vs. chemotherapy and bevacizumab in patients with advanced ovarian cancer without tumour BRCA mutations in the DUO-O Phase III trial astrazeneca.com ↗
Positive results from a planned interim analysis of the DUO-O Phase III trial showed that treatment with a combination of Lynparza (olaparib), Imfinzi (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations. |
| 2023-06-01 | Merck Sharp & Dohme LLC | Regulatory FDA Approves LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). |
| 2023-06-01 | AstraZeneca | Regulatory Lynparza plus abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). |
| 2023-05-26 | AstraZeneca | Results Imfinzi plus Lynparza and Imfinzi alone both significantly improved progression-free survival in advanced endometrial cancer when added to chemotherapy astrazeneca.com ↗
Positive high-level results from the DUO-E Phase III trial showed Imfinzi (durvalumab) in combination with platinum-based chemotherapy followed by either Imfinzi plus Lynparza (olaparib) or Imfinzi alone as maintenance therapy both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy alone in patients with newly diagnosed advanced or recurrent endometrial cancer. |
| 2023-04-28 | Merck Sharp & Dohme LLC | Regulatory Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer merck.com ↗
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCA m mCRPC patients, recommending against approval beyond this patient population. |
| 2023-04-28 | AstraZeneca | Regulatory Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer astrazeneca.com ↗
The Committee voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation. |
| 2023-04-05 | AstraZeneca | Results Lynparza and Imfinzi combination improved progression-free survival in newly diagnosed patients with advanced ovarian cancer without tumour BRCA mutations in DUO-O Phase III trial astrazeneca.com ↗ |
| 2023-03-02 | Merck Sharp & Dohme LLC | Regulatory Merck and AstraZeneca Provide Update on US Regulatory Review of LYNPARZA® (olaparib) for Use in Combination With Abiraterone and Prednisone or Prednisolone for the Treatment of Metastatic Castration-Resistant Prostate Cancer merck.com ↗
The ODAC Meeting is scheduled for April 28, 2023. |
| 2023-03-02 | AstraZeneca | Regulatory Update on US regulatory review of Lynparza in combination with abiraterone for metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). |
| 2023-02-16 | Merck Sharp & Dohme LLC | Results Merck and AstraZeneca Present Final Results of Key Secondary Overall Survival Endpoint From Phase 3 PROpel Trial at 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium merck.com ↗
This OS trend did not reach statistical significance. |
| 2023-02-16 | AstraZeneca | Results AstraZeneca and MSD present final results of key secondary overall survival endpoint from Phase III PROpel trial at ASCO GU Cancers Symposium astrazeneca.com ↗
Results showed an absolute difference of an additional 7.4 months in median overall survival for Lynparza plus abiraterone in this setting vs. abiraterone alone |
| 2023-02-13 | NATCO Pharma Ltd. | Regulatory NATCO files generic Olaparib Tablets in USA natcopharma.co.in ↗
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Olaparib Tablets 100mg and 150mg. |
| 2022-12-21 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone Approved in the EU as Treatment for Certain Patients With Metastatic Castration-Resistant Prostate Cancer merck.com ↗ |
| 2022-12-21 | AstraZeneca | Regulatory Lynparza in combination with abiraterone approved in the EU as 1st-line treatment for patients with metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the European Union for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy is not clinically indicated. |
| 2022-12-15 | Merck Sharp & Dohme LLC | Regulatory AstraZeneca and Merck Provide Update on US Regulatory Review of LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone as Treatment of Metastatic Castration-Resistant Prostate Cancer merck.com ↗
The purpose of the extension is to provide further time for the full review of the submission. |
| 2022-12-15 | AstraZeneca | Regulatory Update on US regulatory priority review of Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date by three months to provide further time for a full review of the supplementary new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC). |
| 2022-11-14 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone Receives Positive Opinion From EU CHMP as Treatment for Certain Patients With Metastatic Castration-Resistant Prostate Cancer merck.com ↗ |
| 2022-11-14 | AstraZeneca | Regulatory Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as 1st-line treatment for patients with metastatic castration-resistant prostate cancer astrazeneca.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the PROpel Phase III trial which were published in NEJM Evidence in June 2022. |
| 2022-11-10 | Xencor, Inc. | Results Xencor Presents Early Clinical Data from Combination Study of Vudalimab and New Data from Multiple Preclinical-stage XmAb® Programs at the SITC Annual Meeting xencor.com ↗
No immune related adverse events (irAEs) or treatment-related AEs were reported for the patient in Cohort C, who received vudalimab and olaparib, a PARP inhibitor. |
| 2022-09-22 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in China as First-Line Maintenance Treatment With Bevacizumab for Homologous Recombination Deficient (HRD)-Positive Advanced Ovarian Cancer merck.com ↗
This approval provides HRD-positive patients with a new option for first-line maintenance therapy. |
| 2022-09-22 | AstraZeneca | Regulatory Lynparza approved in China as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in China for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy in combination with bevacizumab, and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. |
| 2022-09-09 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) in Combination With Bevacizumab, and as Monotherapy, Demonstrates Clinically Meaningful Long-Term Survival in Certain Patients With First-Line Advanced Ovarian Cancer in Exploratory Analyses of Two Phase 3 Trials merck.com ↗
Five-year follow-up of the Phase 3 PAOLA-1 trial showed LYNPARZA plus bevacizumab provided a clinically meaningful improvement in overall survival in a subgroup of HRD-positive patients, with 65.5% of patients still alive versus 48.4% who received bevacizumab and placebo |
| 2022-09-09 | AstraZeneca | Results Lynparza in combination with bevacizumab, and as a monotherapy, demonstrates clinically meaningful survival benefit in 1st-line advanced ovarian cancer across two Phase III trials astrazeneca.com ↗ |
| 2022-08-25 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in Japan as Adjuvant Treatment for Patients With BRCA-Mutated, HER2-Negative High Recurrent Risk Breast Cancer merck.com ↗ |
| 2022-08-25 | AstraZeneca | Regulatory Lynparza approved in Japan as adjuvant treatment for patients with BRCA-mutated HER2-negative high-risk early breast cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the adjuvant treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer at high risk of recurrence. |
| 2022-08-16 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone for Patients With Metastatic Castration-Resistant Prostate Cancer and Grants Priority Review merck.com ↗ |
| 2022-08-16 | AstraZeneca | Regulatory Lynparza in combination with abiraterone granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). |
| 2022-08-04 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in the EU as Adjuvant Treatment for Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer merck.com ↗ |
| 2022-08-04 | AstraZeneca | Regulatory Lynparza approved in the EU as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. |
| 2022-07-18 | Merck Sharp & Dohme LLC | Results LYNK-003 Trial Evaluating LYNPARZA® (olaparib) With or Without Bevacizumab in Patients With Unresectable or Metastatic Colorectal Cancer to Stop for Futility merck.com ↗
At the pre-specified interim analysis for progression-free survival, the efficacy of LYNPARZA as a monotherapy and in combination with bevacizumab relative to control met the criteria for futility by the DMC and accordingly, both experimental arms will be discontinued. |
| 2022-06-27 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Receives Positive Opinion From EU CHMP as Adjuvant Treatment for Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer merck.com ↗
Today’s recommendation is hopeful news for patients in Europe, as we move closer to setting a potential new standard of care that improves overall survival in patients suitable for treatment with olaparib. |
| 2022-06-27 | AstraZeneca | Regulatory Lynparza recommended for approval in the EU by CHMP as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer astrazeneca.com ↗ |
| 2022-06-21 | Merck Sharp & Dohme LLC | Results Results From Phase 3 PROpel Trial of LYNPARZA® (olaparib) Plus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer Published in NEJM Evidence merck.com ↗
The data published in NEJM Evidence emphasize the therapeutic potential of combining olaparib with abiraterone and prednisone and demonstrate efficacy in a wider group of patients beyond those with documented DNA repair deficiency. |
| 2022-04-08 | Cardiff Oncology | Results Cardiff Oncology Announces Data Showing the Combination of PARP Inhibition with Onvansertib Overcomes PARP Inhibitor Resistance in BRCA1-mutant and Wildtype Patient-Derived Xenograft Ovarian Cancer Models cardiffoncology.com ↗
Combining onvansertib with the PARP inhibitor (PARPi) olaparib led to statistically significant survival benefits compared to treatment with either agent alone in PARPi-resistant ovarian cancer models |
| 2022-03-16 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Reduced Risk of Death by 32% in Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer in Phase 3 OlympiA Trial merck.com ↗
In the key secondary endpoint of OS, LYNPARZA reduced the risk of death by 32% (HR=0.68 [98.5% CI, 0.47-0.97]; p=0.009) versus placebo. |
| 2022-03-16 | AstraZeneca | Results Lynparza reduced risk of death by 32% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer astrazeneca.com ↗
Further positive results from the OlympiA Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy. |
| 2022-03-15 | Merck Sharp & Dohme LLC | Results Merck Announces KEYLYNK-010 Trial Evaluating KEYTRUDA® (pembrolizumab) in Combination with LYNPARZA® (olaparib) in Patients with Metastatic Castration-Resistant Prostate Cancer to Stop for Futility merck.com ↗
At the interim analysis, the combination of KEYTRUDA and LYNPARZA did not demonstrate a benefit in overall survival (OS), one of the study’s dual primary endpoints, compared to the control arm of either abiraterone acetate or enzalutamide. |
| 2022-03-11 | Merck Sharp & Dohme LLC | Regulatory FDA Approves LYNPARZA® (olaparib) as Adjuvant Treatment for Patients With Germline BRCA-Mutated (gBRCAm), HER2-Negative High-Risk Early Breast Cancer Who Have Been Treated With Neoadjuvant or Adjuvant Chemotherapy merck.com ↗ |
| 2022-03-11 | AstraZeneca | Regulatory Lynparza approved in the US as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the US for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. |
| 2022-03-08 | Cardiff Oncology | Results Cardiff Oncology Announces Upcoming Poster Presentations at the AACR Annual Meeting cardiffoncology.com ↗
This abstract includes preclinical data that demonstrate the potent anti-tumor activity of onvansertib combined with the PARP inhibitor olaparib in olaparib-resistant ovarian cancer models. |
| 2022-02-22 | MSD R&D (China) Co., Ltd. | Results LYNPARZA®（オラパリブ）、アビラテロンとの併用療法が、 転移性去勢抵抗性前立腺がん（mCRPC）の一次治療において、バイオマーカーのステータスに かかわらず疾患進行または死亡のリスクをアビラテロンと比較して34%減少 PROpel試験は第3相試験として初めて、mCRPCの一次治療において PARP阻害剤との併用で画像診断に基づく無増悪生存期間の臨床的有用性を示す msd.co.jp ↗
LYNPARZA ® とアビラテロン＋プレドニゾロンの併用療法（399例）では、mCRPC患者において、HRR関連遺伝子変異の有無にかかわらず、アビラテロン＋プレドニゾロンおよびプラセボ（397例）と比較して、疾患進行または死亡のリスクが34%低下しました（HR=0.66 [95% CI, 0.54-0.81]; p<0.0001）。 |
| 2022-02-14 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Plus Abiraterone Reduced Risk of Disease Progression or Death by 34% Versus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer, Regardless of Biomarker Status merck.com ↗ |
| 2022-02-14 | AstraZeneca | Results Lynparza plus abiraterone reduced risk of disease progression by 34% vs. standard-of-care in 1st-line metastatic castration-resistant prostate cancer astrazeneca.com ↗ |
| 2022-01-13 | AstraZeneca | Results AstraZeneca aims to redefine liver, biliary tract and prostate cancer treatment with practice-changing Imfinzi and Lynparza data at ASCO GI and GU astrazeneca.com ↗
A late-breaking presentation will showcase the results from the PROpel Phase III trial of Lynparza (olaparib) plus abiraterone, which showed the combination significantly delayed disease progression in 1st-line metastatic castration-resistant prostate cancer (mCRPC) regardless of biomarker status. |
| 2021-11-30 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) as Adjuvant Treatment in BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer and Grants Priority Review merck.com ↗ |
| 2021-11-30 | AstraZeneca | Regulatory Lynparza granted Priority Review in the US for BRCA-mutated HER2-negative high-risk early breast cancer astrazeneca.com ↗
AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) has been accepted and granted Priority Review in the US for the adjuvant treatment of patients with BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. |
| 2021-09-24 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) in Combination With Abiraterone Significantly Delayed Disease Progression in Patients Regardless of Biomarker Status in PROpel Phase 3 Trial in First-Line Metastatic Castration-Resistant Prostate Cancer (mCRPC) merck.com ↗
At a planned interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint of rPFS in men with mCRPC who had not received treatment in the first-line setting, including new hormonal agents (NHAs) or chemotherapy. |
| 2021-09-24 | AstraZeneca | Results Lynparza in combination with abiraterone significantly delayed disease progression in all-comers in PROpel Phase III trial in 1st-line metastatic castration-resistant prostate cancer astrazeneca.com ↗
The trial also showed a trend at this interim analysis towards improved overall survival (OS). |
| 2021-06-24 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in China for the Treatment of Certain Patients with BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer merck.com ↗
LYNPARZA has been granted conditional approval in China |
| 2021-06-24 | AstraZeneca | Regulatory Lynparza approved in China for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD's Lynparza (olaparib) has been granted conditional approval in China to treat adult patients with germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following treatment that included a new hormonal agent (abiraterone, enzalutamide). |
| 2021-06-14 | Fusion Pharmaceuticals Inc. | Results Combination of IGF-1R Targeted Alpha Therapy with Olaparib Results in Synergistic Efficacy Against Colorectal and Lung Cancer Xenografts fusionpharma.com ↗
Combination of IGF-1R targeted alpha therapy with olaparib results in synergistic efficacy against colorectal and lung cancer xenografts. |
| 2021-06-03 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Reduced the Risk of Invasive Disease Recurrence or Death by 42% Versus Placebo in Adjuvant Treatment of Patients With Germline BRCA Mutations and High-Risk HER2-Negative Early Breast Cancer in Phase 3 OlympiA Trial merck.com ↗
In the overall trial population of 1,836 patients, results showed LYNPARZA (n=921) reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% (HR=0.58 [99.5% CI, 0.41-0.82]; p<0.0001) versus placebo (n=915) |
| 2021-06-03 | AstraZeneca | Results Lynparza reduced the risk of cancer recurrence by 42% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer in OlympiA Phase III trial astrazeneca.com ↗ |
| 2021-05-20 | Chugai Pharmaceutical | Regulatory Chugai Obtains Approval for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a Companion Diagnostic for Olaparib in BRCA -Mutated Prostate Cancer chugai-pharm.co.jp ↗
FoundationOne Liquid CDx Cancer Genomic Profile has been approved for use as a companion diagnostic for olaparib in advanced prostate cancer |
| 2021-05-19 | AstraZeneca | Results AstraZeneca ASCO 2021 data support ambition to revolutionise cancer outcomes by treating earlier and transforming the patient experience astrazeneca.com ↗
Lynparza is the first targeted medicine to show clinical benefit in the adjuvant setting for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer |
| 2021-05-05 | Fusion Pharmaceuticals Inc. | Results Combination of IGF-1R Targeted Alpha Therapy with Olaparib Results in Synergistic Efficacy Against Colorectal and Lung Cancer Xenografts fusionpharma.com ↗ |
| 2021-04-06 | Bayer | Results Bayer to present new clinical data in indolent non-Hodgkin’s Lymphoma and additional research on its oncology portfolio at AACR Annual Meeting 2021 bayer.com ↗
A featured presentation will highlight the PSMA-TTC BAY 2315497, targeting prostate specific membrane antigen (PSMA) in prostate cancer cells, showing synergistic anti-tumor activity in combination with PARP inhibitor olaparib in preclinical prostate cancer models. |
| 2021-02-17 | Merck Sharp & Dohme LLC | Results Independent Data Monitoring Committee Concludes OlympiA Trial of LYNPARZA® (olaparib) Crossed Superiority Boundary for Invasive Disease-Free Survival vs. Placebo at Planned Interim Analysis merck.com ↗ |
| 2021-02-17 | AstraZeneca | Results IDMC has concluded that OlympiA trial of Lynparza crossed superiority boundary for invasive disease-free survival vs. placebo at planned interim analysis astrazeneca.com ↗ |
| 2020-12-28 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Receives Three New Approvals in Japan merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that LYNPARZA has been approved in Japan for the treatment of three types of advanced cancer: ovarian, prostate and pancreatic cancer. |
| 2020-12-28 | Chugai Pharmaceutical | Regulatory Chugai Obtains Approval for Expanded Use of FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic for Olaparib in BRCA - Mutated Prostate Cancer chugai-pharm.co.jp ↗
Olaparib was approved on December 25 for the treatment of BRCA -mutated castrate-resistant prostate cancer with distant metastasis |
| 2020-12-28 | AstraZeneca | Regulatory Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers. |
| 2020-11-05 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) in Combination with Bevacizumab Approved in the EU as First-Line Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer merck.com ↗ |
| 2020-11-05 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in the EU for Treatment of BRCA1/2-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that LYNPARZA has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) who have progressed following a prior therapy that included a new hormonal agent. |
| 2020-11-05 | AstraZeneca | Regulatory Lynparza approved in the EU as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer. |
| 2020-11-05 | AstraZeneca | Regulatory Lynparza approved in the EU for the treatment of BRCA- mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations. |
| 2020-09-21 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Recommended for Approval in EU by CHMP as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer merck.com ↗ |
| 2020-09-21 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Receives Positive Opinion from EU CHMP for Treatment of BRCA1/2 Metastatic Castration-Resistant Prostate Cancer (mCRPC) merck.com ↗
This recommendation for LYNPARZA brings us closer to making it the only PARP inhibitor to improve overall survival in this setting available to men in the EU. |
| 2020-09-21 | AstraZeneca | Regulatory Lynparza recommended for approval in the EU by CHMP for BRCA-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations. |
| 2020-09-21 | AstraZeneca | Regulatory Lynparza recommended for approval in EU by CHMP as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer. |
| 2020-09-20 | Merck Sharp & Dohme LLC | Results LYNPARZA Reduced Risk of Death by 31% vs. Enzalutamide or Abiraterone for Men with BRCA1/2 or ATM-Mutated Metastatic Castration Resistant Prostate Cancer Who Progressed Following Enzalutamide or Abiraterone in Phase 3 PROfound Trial merck.com ↗
Median OS was 19.1 months for LYNPARZA vs. 14.7 months for enzalutamide or abiraterone, despite 66% of men on these treatments having crossed over to receive treatment with LYNPARZA following disease progression. |
| 2020-09-20 | AstraZeneca | Results Lynparza reduced the risk of death by 31% in BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer in PROfound Phase III trial astrazeneca.com ↗
In the key secondary endpoint of OS, Lynparza reduced the risk of death by 31% versus enzalutamide or abiraterone (based on a hazard ratio [HR] of 0.69; 95% confidence interval [CI] 0.50-0.97; p=0.0175). |
| 2020-09-18 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Improved Median Progression-Free Survival to Over Four and a Half Years Compared to 13.8 Months with Placebo for Patients with BRCA-Mutated Advanced Ovarian Cancer merck.com ↗
Five-year follow-up data from the Phase 3 SOLO-1 trial showed LYNPARZA reduced the risk of disease progression or death by 67% (HR 0.33 [95% CI 0.25–0.43]), and improved median PFS to 56 months vs. 13.8 months for placebo. |
| 2020-09-18 | AstraZeneca | Results Lynparza improved median time patients lived without disease progression to over four and half years in BRCA-mutated advanced ovarian cancer vs. just over one year with placebo astrazeneca.com ↗
Five-year follow-up data from the SOLO-1 Phase III trial showed Lynparza reduced the risk of disease progression or death by 67% (based on a hazard ratio [HR] of 0.33; 95% confidence interval [CI] 0.25-0.43) and improved PFS to a median of 56.0 months versus 13.8 months for placebo. |
| 2020-09-08 | AstraZeneca | Results AstraZeneca aims to transform cancer treatment and advance clinical practice with data presented at ESMO 2020 astrazeneca.com ↗
Pivotal overall survival data confirm benefit of Lynparza use in advanced prostate cancer |
| 2020-07-08 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in the EU for Germline BRCA-mutated Metastatic Pancreatic Cancer merck.com ↗ |
| 2020-07-08 | AstraZeneca | Regulatory Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer astrazeneca.com ↗
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been approved in the European Union (EU) for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. |
| 2020-06-01 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Receives Positive Opinion from EU CHMP for First-Line Maintenance Treatment of Patients with Germline BRCA-Mutated Metastatic Pancreatic Cancer merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending LYNPARZA for approval as monotherapy for the maintenance treatment of adult patients with germline BRCA 1/2 mutations (g BRCA m) who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. |
| 2020-06-01 | AstraZeneca | Regulatory Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer astrazeneca.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine . |
| 2020-05-20 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved by FDA for Treatment of HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer That Has Progressed Following Prior Treatment with Enzalutamide or Abiraterone merck.com ↗
the U.S. Food and Drug Administration (FDA) has approved LYNPARZA |
| 2020-05-20 | AstraZeneca | Regulatory Lynparza approved in the US for HRR gene-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗ |
| 2020-05-11 | AstraZeneca | Regulatory Lynparza approved in the US as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer astrazeneca.com ↗
The approval by the US Food and Drug Administration (FDA) was based on a biomarker subgroup analysis of the Phase III PAOLA-1 trial which showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (equal to a hazard ratio of 0.33). |
| 2020-05-08 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer merck.com ↗ |
| 2020-04-24 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Demonstrated Overall Survival Benefit in Phase 3 PROfound Trial for BRCA1/2 or ATM-Mutated Metastatic Castration-Resistant Prostate Cancer merck.com ↗ |
| 2020-04-24 | AstraZeneca | Results Lynparza demonstrated overall survival benefit in Phase III PROfound trial for BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
Only PARP inhibitor to improve overall survival vs. new hormonal agent treatments for this advanced prostate cancer population with high unmet needs |
| 2020-03-19 | AstraZeneca | Regulatory Lynparza granted orphan drug designation in Japan for BRCA-mutated metastatic pancreatic cancer astrazeneca.com ↗
AstraZeneca today announced that Lynparza (olaparib) has been granted orphan drug designation (ODD) in Japan for the maintenance treatment of germline BRCA-mutated (gBRCAm) curatively unresectable pancreatic cancer. |
| 2020-03-12 | Merck Sharp & Dohme LLC | Results Update on Phase 3 GY004 for Cediranib and LYNPARZA® (olaparib) in Platinum-Sensitive Relapsed Ovarian Cancer merck.com ↗
The trial did not meet the primary endpoint in the intent-to-treat (ITT) population of a statistically significant improvement in progression-free survival (PFS) with cediranib in combination with LYNPARZA vs. platinum-based chemotherapy. |
| 2020-03-12 | AstraZeneca | Results Update on Phase III GY004 trial for cediranib added to Lynparza in platinum-sensitive relapsed ovarian cancer astrazeneca.com ↗
The trial did not meet the primary endpoint in the intent-to-treat (ITT) population of a statistically significant improvement in progression-free survival (PFS) with cediranib added to Lynparza versus platinum-based chemotherapy. |
| 2020-01-21 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) in HRR-Mutated Metastatic Castration-Resistant Prostate Cancer and Grants Priority Review merck.com ↗
The sNDA acceptance for review by the FDA is based on positive results from the Phase 3 PROfound trial, which were presented during a Presidential Symposium at the 2019 European Society of Medical Oncology congress. |
| 2020-01-20 | AstraZeneca | Regulatory Lynparza regulatory submission granted Priority Review in the US for HRR-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗ |
| 2020-01-13 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) as First-Line Maintenance with Bevacizumab in Advanced Ovarian Cancer and Grants Priority Review merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with bevacizumab has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of women with advanced ovarian cancer whose disease showed a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. |
| 2020-01-13 | AstraZeneca | Regulatory Lynparza regulatory submission granted Priority Review in the US for 1st-line maintenance treatment with bevacizumab in advanced ovarian cancer astrazeneca.com ↗ |
| 2019-12-30 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. |
| 2019-12-30 | AstraZeneca | Regulatory Lynparza approved in the US as a 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer astrazeneca.com ↗ |
| 2019-12-17 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy merck.com ↗
Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results |
| 2019-12-17 | AstraZeneca | Regulatory Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer astrazeneca.com ↗
ODAC voted that Lynparza demonstrated a clinically meaningful and favourable risk-benefit profile for patients based on Phase III POLO trial results |
| 2019-12-05 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer merck.com ↗ |
| 2019-12-05 | AstraZeneca | Regulatory Lynparza approved in China as a 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer astrazeneca.com ↗
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the companies have received marketing authorisation from China’s National Medical Products Administration (NMPA) for Lynparza (olaparib) as a 1st-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy. |
| 2019-11-13 | Valerio Therapeutics | Results Onxeo Announces Publication of Preclinical Study Results Comparing Efficacy and Toxicity of olaparib and AsiDNA™ in Frontiers in Oncology valeriotx.com ↗
In-vivo models showed that, while both DNA repair inhibitors were effective, only AsiDNA™ could delay resistance to carboplatin without increasing its toxicity. |
| 2019-09-30 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) More Than Doubled Median Radiographic Progression-Free Survival (rPFS) in BRCA1/2 or ATM Metastatic Castration-Resistant Prostate Cancer vs. Standard of Care (7.4 vs. 3.6 months) merck.com ↗
LYNPARZA reduced the risk of disease progression or death by 66% for these men. |
| 2019-09-30 | AstraZeneca | Results Lynparza more than doubled the time without radiographic disease progression in patients with BRCA1/2- or ATM-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
Lynparza reduced the risk of disease progression or death by 66% (equal to a hazard ratio of 0.34) for these men. |
| 2019-09-30 | AstraZeneca | Results Lynparza improved the time women lived without disease progression to 22 months in the broad population and to 37 months in HRD-positive patients as 1st-line maintenance treatment with bevacizumab for newly-diagnosed advanced ovarian cancer astrazeneca.com ↗
At two years since trial initiation, 46% of women treated with Lynparza added to bevacizumab showed no disease progression vs. 28% of women receiving bevacizumab alone. |
| 2019-09-28 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Phase 3 PAOLA-1 Trial Significantly Increased Progression-Free Survival as First-Line Maintenance Treatment with Bevacizumab for Newly-Diagnosed Advanced Ovarian Cancer merck.com ↗
AstraZeneca and Merck’s LYNPARZA Added to Bevacizumab Reduced the Risk of Disease Progression or Death by 41% in the Overall Trial Population of Women Who Responded to Platinum-Based Chemotherapy |
| 2019-09-16 | AstraZeneca | Results AstraZeneca redefines cancer treatment with practice-changing data at ESMO 2019 astrazeneca.com ↗
PAOLA-1 is the second positive Phase III trial for Lynparza in 1st-line advanced ovarian cancer. |
| 2019-09-11 | Starpharma Pty Ltd | Results DEP irinotecan synergistic with Lynparza in refractory model starpharma.com ↗
The combination of DEP® irinotecan and Lynparza® (olaparib) provided significantly enhanced and synergistic anti-tumour efficacy compared to either drug alone, and compared to the combination of Lynparza® (olaparib) with the standard form of irinotecan. |
| 2019-08-14 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Phase 3 PAOLA-1 Trial Met Primary Endpoint as First-Line Maintenance Treatment with Bevacizumab for Advanced Ovarian Cancer merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 PAOLA-1 trial in women with advanced ovarian cancer. |
| 2019-08-14 | AstraZeneca | Results Lynparza Phase III PAOLA-1 trial met primary endpoint as 1st-line maintenance treatment with bevacizumab for advanced ovarian cancer astrazeneca.com ↗
The trial met its primary endpoint in the intent-to-treat* population with a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time women taking Lynparza plus bevacizumab lived without disease progression or death vs. those taking bevacizumab alone. |
| 2019-08-07 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Phase 3 PROfound Trial in HRR Mutation-Selected Metastatic Castration-Resistant Prostate Cancer Met Primary Endpoint merck.com ↗
AstraZeneca and Merck’s LYNPARZA Improved Radiographic Progression Free Survival vs. Standard of Care in Patients Selected for BRCA 1/2 or ATM Mutations |
| 2019-08-07 | AstraZeneca | Results Lynparza Phase III PROfound trial in HRR* mutation-selected metastatic castration-resistant prostate cancer met primary endpoint astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza met the primary endpoint of significantly increasing the time patients selected for BRCA1/2 or ATM mutations live without radiographic disease progression vs. standard of care treatment |
| 2019-06-19 | Merck Sharp & Dohme LLC | Regulatory AstraZeneca and Merck’s LYNPARZA® (olaparib) Approved in Japan as First-Line Maintenance Therapy in Patients with BRCA-Mutated Advanced Ovarian Cancer merck.com ↗
LYNPARZA is the Only PARP Inhibitor Approved in Japan |
| 2019-06-19 | AstraZeneca | Regulatory Lynparza approved in Japan for 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza is the only PARP inhibitor approved in Japan |
| 2019-06-18 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in the EU for Use as First-Line Maintenance Therapy in Patients With BRCA-Mutated Advanced Ovarian Cancer merck.com ↗ |
| 2019-06-18 | AstraZeneca | Regulatory Lynparza approved in the EU for 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer astrazeneca.com ↗
today announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. |
| 2019-06-03 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Phase 3 SOLO3 Trial Demonstrated a 72% Objective Response Rate in Patients with Platinum-Sensitive Relapsed Germline BRCA-mutated Advanced Ovarian Cancer Compared to 51% of Patients Receiving Chemotherapy merck.com ↗
The results from the trial showed a statistically-significant and clinically-meaningful improvement in objective response rate (ORR) in the LYNPARZA arm compared to the chemotherapy arm (ORR; 72.2% for LYNPARZA vs 51.4% for chemotherapy; 95% CI: 1.40 to 4.58; p=0.002). |
| 2019-06-03 | AstraZeneca | Results Lynparza nearly doubled the time patients lived without disease progression from germline BRCA-mutated metastatic pancreatic cancer astrazeneca.com ↗
More than twice as many patients showed no disease progression both at one year (34% on Lynparza vs. 15% on placebo) and two years (22% vs. 10%, respectively). |
| 2019-06-03 | AstraZeneca | Results Lynparza achieved a 72% objective response rate in patients with relapsed, germline BRCA-mutated advanced ovarian cancer astrazeneca.com ↗
The trial also met the key secondary endpoint of progression-free survival (PFS), demonstrating a statistically-significant and clinically-meaningful improvement in the time patients lived without disease progression for Lynparza (13.4 months) vs. chemotherapy (9.2 months [HR 0.62] p=0.013]). |
| 2019-06-02 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) First-Line Maintenance Therapy Nearly Doubled the Time Without Disease Progression or Death in Phase 3 POLO Trial for Patients with Germline BRCA-Mutated Metastatic Pancreatic Cancer merck.com ↗
Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for LYNPARZA compared to placebo, reducing the risk of disease progression or death by 47% (HR 0.53 [95% CI 0.35-0.82], p=0.004). |
| 2019-06-02 | AstraZeneca | Results Lynparza nearly doubled the time patients lived without disease progression from germline BRCA-mutated metastatic pancreatic cancer astrazeneca.com ↗
Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza vs. placebo, improving the time without disease progression by a median of 7.4 months for patients treated with Lynparza vs. 3.8 months for those on placebo (HR 0.53 [95% CI, 0.35-0.82], p=0.004). |
| 2019-05-16 | AstraZeneca | Results AstraZeneca continues to redefine cancer treatment at the 2019 ASCO Annual Meeting astrazeneca.com ↗
Late-breaking results from the Lynparza POLO trial, the first positive Phase III trial of any PARP inhibitor in germline BRCA -mutated (g BRCA m) metastatic pancreatic cancer, a devastating diagnosis with critical unmet medical need. |
| 2019-04-29 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion for First-Line Maintenance Treatment in BRCA-Mutated Advanced Ovarian Cancer merck.com ↗ |
| 2019-04-29 | AstraZeneca | Regulatory Lynparza receives positive EU CHMP opinion for 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer astrazeneca.com ↗ |
| 2019-04-10 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in EU for the Treatment of Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer merck.com ↗
First PARP Inhibitor Approved in the EU for This Indication and Third EU Approval for LYNPARZA |
| 2019-04-10 | AstraZeneca | Regulatory Lynparza approved in EU for the treatment of germline BRCA-mutated HER2-negative advanced breast cancer astrazeneca.com ↗
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced the European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA 1/2-mutations (g BRCA m), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer. |
| 2019-03-29 | Chugai Pharmaceutical | Regulatory Chugai Files an Application for Expanded Use of Genomic Mutation Analysis Program “FoundationOne CDx Cancer Genomic Profile” as a Companion Diagnostic of Lynparza chugai-pharm.co.jp ↗ |
| 2019-03-01 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion For Use in Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer merck.com ↗
The positive opinion from CHMP for LYNPARZA in this patient population is an important milestone. |
| 2019-03-01 | AstraZeneca | Regulatory Lynparza receives positive EU CHMP opinion for use in germline BRCA-mutated HER2-negative advanced breast cancer astrazeneca.com ↗
The positive opinion from CHMP for Lynparza in this patient population is an important milestone. |
| 2019-02-26 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Reduced the Risk of Disease Progression or Death as First-Line Maintenance Treatment in Germline BRCA-Mutated Metastatic Pancreatic Cancer merck.com ↗
AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 POLO trial. |
| 2019-02-26 | AstraZeneca | Results Lynparza significantly delayed disease progression as 1st-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer astrazeneca.com ↗
Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Lynparza (olaparib) vs. placebo. |
| 2019-02-14 | Merck Sharp & Dohme LLC | Results Merck Increases Focus on Advanced Prostate Cancer, Expanding Immuno-Oncology Program with Three New Phase 3 Trials merck.com ↗
Research Program Expanded Based on Promising Data Shown with KEYTRUDA ® (pembrolizumab) in Combination with LYNPARZA ® (olaparib), Chemotherapy and Anti-Hormone Agents in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
| 2018-12-20 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Meets Primary Endpoint in Phase 3 SOLO-3 Trial for the Treatment of Relapsed BRCA-Mutated Advanced Ovarian Cancer merck.com ↗
This is the fourth Phase 3 trial to demonstrate a positive result for LYNPARZA. |
| 2018-12-20 | AstraZeneca | Results Lynparza meets primary endpoint in Phase III SOLO-3 trial for the treatment of relapsed BRCA-mutated advanced ovarian cancer astrazeneca.com ↗
This is the fourth Phase III trial to demonstrate a positive result for Lynparza. |
| 2018-12-19 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved by FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer merck.com ↗
This is the first regulatory approval for a PARP inhibitor in the first-line maintenance setting for BRCA m advanced ovarian cancer. |
| 2018-12-19 | AstraZeneca | Regulatory Lynparza approved by US FDA for 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer astrazeneca.com ↗
This is the first regulatory approval for a PARP inhibitor in the 1st-line maintenance setting for BRCA m advanced ovarian cancer. |
| 2018-11-12 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Regulatory Submission for LYNPARZA® (olaparib) Maintenance Therapy in Newly-Diagnosed, BRCA-Mutated Advanced Ovarian Cancer and Grants Priority Review merck.com ↗
This is the first U.S. regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the first-line maintenance setting for advanced ovarian cancer, and, if approved, will be the fourth indication for LYNPARZA in the U.S. |
| 2018-11-12 | AstraZeneca | Regulatory US FDA accepts regulatory submission for Lynparza maintenance therapy in newly-diagnosed, BRCA-mutated advanced ovarian cancer and grants Priority Review astrazeneca.com ↗ |
| 2018-10-22 | AstraZeneca | Results SOLO-1 Phase III trial demonstrates Lynparza maintenance therapy cut risk of disease progression or death by 70% in patients with newly-diagnosed, advanced BRCA-mutated ovarian cancer astrazeneca.com ↗
Results of the trial confirm the statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza compared to placebo, reducing the risk of disease progression or death by 70% (HR 0.30 [95% CI 0.23-0.41], p<0.001). |
| 2018-10-21 | Merck Sharp & Dohme LLC | Results SOLO-1 Phase 3 Trial Demonstrates LYNPARZA® (olaparib) Maintenance Therapy Cut the Risk of Disease Progression or Death by 70 Percent in Patients with Newly-Diagnosed, Advanced BRCA-Mutated Ovarian Cancer merck.com ↗
Results of the trial confirm the statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for LYNPARZA as compared to placebo, reducing the risk of disease progression or death by 70 percent (HR=0.30 [95% CI, 0.23-0.41]; p<0.001). |
| 2018-10-16 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Grants LYNPARZA® (olaparib) Orphan Drug Designation for Pancreatic Cancer merck.com ↗
AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for LYNPARZA for the treatment of pancreatic cancer. |
| 2018-10-16 | AstraZeneca | Regulatory US FDA grants Lynparza Orphan Drug Designation for pancreatic cancer astrazeneca.com ↗
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that they were granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer. |
| 2018-10-09 | AstraZeneca | Results AstraZeneca presents advances in improving treatment options for ovarian and lung cancer patients at ESMO 2018 Congress astrazeneca.com ↗
New Lynparza data demonstrate clinically-meaningful improvement for newly-diagnosed, advanced BRCA-mutated ovarian cancer |
| 2018-07-02 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Approved in Japan for BRCA-Mutated Metastatic Breast Cancer merck.com ↗
This latest approval underlines our ongoing efforts to make LYNPARZA available across multiple cancers as quickly as possible to patients around the world. |
| 2018-07-02 | AstraZeneca | Regulatory Lynparza approved in Japan for BRCA-mutated metastatic breast cancer astrazeneca.com ↗ |
| 2018-06-27 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Significantly Delays Disease Progression in Phase 3 First-Line SOLO-1 Trial for Ovarian Cancer merck.com ↗
Women with BRCA- mutated ( BRCA m) advanced ovarian cancer treated first-line with LYNPARZA maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo. |
| 2018-06-27 | AstraZeneca | Results Lynparza significantly delays disease progression in Phase III 1st-line SOLO-1 trial for ovarian cancer astrazeneca.com ↗
Women with BRCA- mutated (BRCA m ) advanced ovarian cancer treated 1st-line with Lynparza maintenance therapy had a statistically-significant and clinically-meaningful improvement in progression-free survival compared to placebo. |
| 2018-06-04 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) in Combination with Abiraterone Delayed Disease Progression in Metastatic Castration-Resistant Prostate Cancer merck.com ↗ |
| 2018-06-04 | AstraZeneca | Results Lynparza in combination with abiraterone delayed disease progression in metastatic castration-resistant prostate cancer astrazeneca.com ↗
today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with Lynparza (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a standard of care, in metastatic castration-resistant prostate cancer (mCRPC). |
| 2018-05-08 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Tablets Receive EU Approval for the Treatment of Platinum-Sensitive Relapsed Ovarian Cancer merck.com ↗ |
| 2018-05-08 | AstraZeneca | Regulatory Lynparza tablets receive EU approval for the treatment of platinum-sensitive relapsed ovarian cancer astrazeneca.com ↗
The EU approval was based on two randomised trials, SOLO-2 and Study 19, which showed that Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo. |
| 2018-04-15 | Merck Sharp & Dohme LLC | Results Updated Overall Survival Data for LYNPARZA® (olaparib) in gBRCA-mutated HER2-Negative Metastatic Breast Cancer Presented at AACR merck.com ↗
While the trial was not powered to demonstrate a statistically significant difference, the median OS was 19.3 months in patients treated with LYNPARZA and 17.1 months for patients treated with chemotherapy (HR 0.90, 95% CI 0.66-1.23; p=0.513). |
| 2018-04-15 | AstraZeneca | Results Updated overall survival data for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer presented at AACR astrazeneca.com ↗
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data from the Phase III OlympiAD trial showing the final overall survival (OS) results for Lynparza (olaparib) in metastatic breast cancer at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, US, 14-18 April 2018. |
| 2018-04-04 | AstraZeneca | Results AstraZeneca’s early and late-stage oncology portfolio showcased at AACR annual meeting and ELCC astrazeneca.com ↗
The PARP inhibitor olaparib is synergistic with the ATR inhibitor AZD6738 in ATM deficient cancer cells |
| 2018-04-03 | Merck Sharp & Dohme LLC | Regulatory The European Medicines Agency Accepts Regulatory Submission for LYNPARZA® (olaparib) in BRCA-Mutated HER2-Negative Metastatic Breast Cancer merck.com ↗ |
| 2018-04-03 | AstraZeneca | Regulatory The European Medicines Agency accepts regulatory submission for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the European Medicines Agency has validated for review the Marketing Authorisation Application (MAA) for Lynparza (olaparib) for use in patients with deleterious or suspected deleterious BRCA -mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. |
| 2018-03-18 | Patrys Ltd. | Results PAT-DX1 Improves Survival in Animal Model of Glioblastoma patrys.com ↗
PAT-DX1 alone was superior to olaparib alone, and the addition of olaparib to PAT-DX1 did not yield any significant improvement over PAT-DX1 alone. |
| 2018-02-23 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion in Platinum-Sensitive Relapsed Ovarian Cancer merck.com ↗ |
| 2018-02-23 | AstraZeneca | Regulatory Lynparza receives positive EU CHMP opinion in platinum-sensitive relapsed ovarian cancer astrazeneca.com ↗
Lynparza is recommended for treatment in this setting regardless of patients’ BRCA mutation status. |
| 2018-01-19 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) Receives Approval in Japan for the Treatment of Advanced Ovarian Cancer merck.com ↗
LYNPARZA is the first poly ADP-ribose polymerase (PARP) inhibitor to be approved in Japan. |
| 2018-01-19 | AstraZeneca | Regulatory Lynparza receives approval in Japan for the treatment of advanced ovarian cancer astrazeneca.com ↗
Lynparza is the first PARP inhibitor approved in Japan |
| 2018-01-12 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Approves LYNPARZA® (olaparib) in Germline BRCA-Mutated Metastatic Breast Cancer merck.com ↗
This new approval for LYNPARZA makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved outside of ovarian cancer. |
| 2018-01-12 | AstraZeneca | Regulatory Lynparza approved by US FDA in germline BRCA-mutated metastatic breast cancer astrazeneca.com ↗
Lynparza is the first and only PARP inhibitor approved for use beyond ovarian cancer |
| 2017-10-23 | Merck Sharp & Dohme LLC | Regulatory AstraZeneca and Merck Rapidly Advance LYNPARZA® (olaparib) in Japan With a Second Regulatory Submission merck.com ↗ |
| 2017-10-23 | AstraZeneca | Regulatory AstraZeneca and MSD rapidly advance Lynparza in Japan with a second regulatory submission astrazeneca.com ↗
This is the second NDA for Lynparza in Japan where the medicine is currently under review for use in ovarian cancer, with a PMDA decision for this indication anticipated in the first half of 2018. |
| 2017-10-18 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Accepts Regulatory Submission for LYNPARZA® (olaparib) in Metastatic Breast Cancer and Grants Priority Review merck.com ↗ |
| 2017-10-18 | AstraZeneca | Regulatory US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants Priority Review astrazeneca.com ↗ |
| 2017-08-17 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA Receives Additional and Broad Approval in the U.S. for Ovarian Cancer merck.com ↗
AstraZeneca and Merck & Co., Inc. (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, LYNPARZA (olaparib), as follows: |
| 2017-08-17 | AstraZeneca | Regulatory Lynparza receives additional and broad approval in the US for ovarian cancer astrazeneca.com ↗
AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the U.S. and Canada) today announced that the US Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza (olaparib), as follows: |
| 2017-06-04 | AstraZeneca | Results Lynparza significantly reduces the risk of disease worsening or death in patients with BRCA-mutated metastatic breast cancer astrazeneca.com ↗ |
| 2017-05-26 | AstraZeneca | Results AstraZeneca delivers new data on expanding portfolio of cancer medicines at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting astrazeneca.com ↗
‘Late-breaker’ data from the OlympiAD trial of Lynparza (olaparib) versus chemotherapy in BRCA-mutated metastatic breast cancer (Abstract #LBA4) are the first positive Phase III results for a poly ADP-ribose polymerase (PARP) inhibitor beyond ovarian cancer. |
| 2017-03-14 | AstraZeneca | Results Lynparza Phase III SOLO-2 data demonstrate progression-free survival benefit in BRCA-mutated ovarian cancer as maintenance therapy astrazeneca.com ↗
The trial met its primary endpoint of investigator assessed PFS (HR 0.30; 95% CI 0.22 to 0.41; P<0.0001; median 19.1 months vs 5.5 months). |
| 2017-02-17 | AstraZeneca | Results Lynparza meets primary endpoint in Phase III trial in BRCA-mutated metastatic breast cancer astrazeneca.com ↗
Patients treated with Lynparza showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared with those who received chemotherapy (capecitabine, vinorelbine or eribulin). |
| 2016-11-03 | AbbVie | Results ImmunoGen Announces Preclinical Data Presentations for Two ADCs With Novel IGN Payloads at Upcoming 58th ASH Annual Meeting abbvie.com ↗
Combining IMGN779, a Novel Anti-CD33 Antibody-Drug Conjugate (ADC), with the PARP Inhibitor, Olaparib, Results in Enhanced Anti-Tumor Activity in Preclinical Acute Myeloid Leukemia (AML) Models |
| 2016-10-26 | AstraZeneca | Results Lynparza Phase III SOLO-2 trial shows significant progression-free survival benefit astrazeneca.com ↗
AstraZeneca today announced positive results from the Phase III SOLO-2 trial designed to determine the efficacy of Lynparza (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer. |
| 2016-05-18 | AstraZeneca | Results AstraZeneca provides top-line results from Lynparza GOLD trial in advanced gastric cancer astrazeneca.com ↗
AstraZeneca today announced that Lynparza (olaparib) in combination with paclitaxel chemotherapy, compared with paclitaxel chemotherapy alone, did not meet the primary endpoint of overall survival (OS) in the Phase III GOLD trial in advanced gastric cancer patients, in either the overall population or patients whose tumour tested negative for Ataxia-Telangectasia Mutated (ATM) protein. |
| 2016-01-28 | AstraZeneca | Regulatory Lynparza™ (olaparib) granted Breakthrough Therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer astrazeneca.com ↗
The Breakthrough Therapy designation for Lynparza in this patient population means the FDA will expedite review of submission data within 60 days of receipt. |
| 2015-09-24 | AstraZeneca | Results AstraZeneca presents advances in oncology research at ECC 2015 with data on AZD9291, durvalumab and LYNPARZA™ (olaparib) astrazeneca.com ↗ |
| 2015-04-17 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Late-Breaking Data at American Association for Cancer Research Annual Meeting karyopharm.com ↗
The combination of selinexor and olaparib was shown to act synergistically to induce apoptosis and amplify anti-tumor effects in mouse model of BRCA1 mutant breast cancer. |
| 2014-12-19 | AstraZeneca | Regulatory LYNPARZA™ approved by the US food and drug administration for the treatment of advanced ovarian cancer in patients with germline BRCA-mutations astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved LYNPARZA™ (olaparib) capsules (400mg twice daily) as the first monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. |
| 2014-12-18 | AstraZeneca | Regulatory Lynparza™approved in the European Union as first-in-class treatment for advanced BRCA-mutated ovarian cancer astrazeneca.com ↗
It is the first PARP inhibitor to be approved for patients with platinum-sensitive relapsed BRCA -mutated ovarian cancer. |
| 2014-10-24 | AstraZeneca | Regulatory Lynparza™ (olaparib) receives positive CHMP opinion in the EU for the maintenance treatment of BRCA-mutated platinum sensitive relapsed ovarian cancer astrazeneca.com ↗
The positive CHMP opinion was based on the results from Study 19 1 , a Phase II clinical trial that evaluated the efficacy and safety of olaparib compared to placebo in platinum sensitive relapsed high grade serous ovarian cancer patients. |
| 2014-06-25 | AstraZeneca | Regulatory FDA Advisory Committee votes on accelerated approval for investigational medicine olaparib astrazeneca.com ↗ |
| 2014-06-03 | AstraZeneca | Results AstraZeneca updates on the rapid progress of its oncology pipeline at ASCO 2014 astrazeneca.com ↗
The data showed that the combination of the two orally-administered investigational medicines nearly doubled the time it took for patients’ tumours to progress (progression-free survival) and improved objective response rate (ORR), compared to treatment with olaparib alone. |
| 2014-05-31 | AstraZeneca | Results AstraZeneca welcomes positive data on the combination of olaparib and cediranib for the treatment of ovarian cancer patients astrazeneca.com ↗
The NCI data is extremely compelling, showing that the combination of olaparib and cediranib nearly doubled the progression-free survival benefit compared to olaparib alone. |
| 2014-05-15 | AstraZeneca | Results Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company astrazeneca.com ↗
Encouraging efficacy data from a randomised Phase II study, conducted by the US National Cancer Institute (NCI), investigating the combination of PARP inhibitor olaparib and VEGF inhibitor cediranib in high-grade serous ovarian cancer. |
| 2014-05-14 | AstraZeneca | Results AstraZeneca to demonstrate the strength and rapid acceleration of its oncology pipeline at ASCO 2014 astrazeneca.com ↗
Encouraging efficacy data shown in a randomised Phase II study, conducted by the US National Cancer Institute (NCI), investigating the combination of PARP inhibitor olaparib and VEGF inhibitor cediranib in high-grade serous ovarian cancer. |
| 2013-09-27 | AstraZeneca | Regulatory Marketing Authorisation Application for olaparib accepted by European Medicines Agency astrazeneca.com ↗
AstraZeneca today announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application (MAA) for olaparib, an investigational poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of patients with BRCA mutated platinum-sensitive relapsed serous ovarian cancer. |
| 2011-12-20 | AstraZeneca | Results AstraZeneca updates on olaparib and TC-5214 development programmes astrazeneca.com ↗
AstraZeneca today announced that its investigational compound olaparib will not progress into Phase III development for the maintenance treatment of serous ovarian cancer. |
All press releases naming this drug 213 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 213 releases opens the full record — a long page | ||
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 446 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Olaparib | “NCI Definition - A small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase (PARP) with potential chemosensitizing, radiosensitizing, and antineoplastic...” NCT06856499 ↗424“This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of olaparib tablets 300 mg (two 150 mg tablets) given orally twice daily...” NCT02983799 ↗ “Other systemic agents, including PARP inhibitors such as olaparib, may be used in combination with ADT and second-generation ARSis according to approved indications, molecular...” NCT07268794 ↗ “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗ “Olaparib, an oral PARP inhibitor, has shown antitumour activity as monotherapy in patients with germline BRCA1/2 (gBRCA)-mutated breast and ovarian cancer.” PMID 25025963 ↗ Jul 2014 “Agents of interest included Abiraterone, Enzalutamide, Pembrolizumab, Ipilimumab, Carboplatin, Docetaxel, and Olaparib as well as combinations” NCT04399876 ↗ “in patients with germline BRCA1/2 mutation eligible to adjuvant olaparib, tiragolumab and atezolizumab will not be resumed after surgery” NCT06175390 ↗ “Olaparib 300 mg BD (2 × 150 mg tablets) continually in the olaparib monotherapy and ceralasertib+olaparib treatment arms.” NCT04239014 ↗ “paclitaxel 80 mg/m² iv weekly in combination with olaparib tablets 100 mg twice daily for 12 weeks (PwO) (65 patients)” NCT02789332 ↗ “200 mg pembrolizumab every 3 weeks plus 300 mg olaparib twice a day (BID) every day starting from Day 1 of Cycle 1.” NCT04825990 ↗ “Participants will receive standard of care PARPi (Olaparib or Talazoparib) therapy in Step 2 and Step 3.” NCT05826964 ↗ |
| Known as | AZ-2281 | ChEMBL registry synonym — accepted as the source's own label CHEMBL521686 ↗ |
| Known as | AZD2281 | “Module B will investigate the safety and tolerability of MEDI4736 given intravenously in combination with olaparib (AZD2281, Lynparza) given orally to selected patients with...” NCT02546661 ↗24“A Randomised, Double Blinded, Multicentre Phase II Study to Assess the Efficacy of Olaparib (AZD2281, KU-0059436) in Combination With Paclitaxel Versus Paclitaxel in Patients...” NCT01063517 ↗ “Phase II Randomized Study of Neoadjuvant Durvalumab (MEDI4736) Alone Versus Durvalumab (MEDI4736) With Olaparib (AZD2281) in Patients Ineligible for Cisplatin With...” NCT04579133 ↗ “A randomized, Double-blinded, Placebo Controlled, Multicentre Phase III Study to Assess the Efficacy and Safety of Olaparib (AZD2281) in Combination With Paclitaxel, Compared...” NCT01924533 ↗ “AZD2281 (KU-0059436) is an oral PARP-1 and PART-2 inhibitor that affects tumor growth by impairing the ability of the cell to repair damaged DNA.” NCT01445418 ↗ “This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer.” NCT00912743 ↗ “Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer” NCT01296763 ↗ “Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone” NCT01513174 ↗ “AZD2281 is an experimental drug in a class of agents called PARP inhibitors.” NCT00678132 ↗ “Olaparib (AZD2281) is an oral PARP-1/2 inhibitor (PARPi)” NCT01237067 ↗ “Olaparib (AZD2281), an Oral PARP Inhibitor” NCT01390571 ↗ |
| Known as | AZD2281 (Olaparib) | “In multiple existing IBC models (SUM-149, SUM-190, MDA-IBC-3), PARPi (AZD2281-olaparib and ABT-888-veliparib) had limited single-agent efficacy (IC50 > 10 μmol/L) in...” PMID 31413177 ↗ Aug 20191“AZD2281 (Olaparib)” NCT03775486 ↗ |
| Known as | KU-0059436 | “A Randomised, Double Blinded, Multicentre Phase II Study to Assess the Efficacy of Olaparib (AZD2281, KU-0059436) in Combination With Paclitaxel Versus Paclitaxel in Patients...” NCT01063517 ↗9“AZD2281 (KU-0059436) is an oral PARP-1 and PART-2 inhibitor that affects tumor growth by impairing the ability of the cell to repair damaged DNA.” NCT01445418 ↗ “Single Oral 100 mg Dose of [14C]-AZD2281 (KU-0059436) in Patients With Advanced or Metastatic Solid Tumours Refractory to Standard Treatments” NCT00633269 ↗ |
| Known as | KU-59436 | ChEMBL registry synonym — accepted as the source's own label CHEMBL521686 ↗ |
| Known as | Lynparza | “An Open Label, Single Arm, Multicentre Study to Assess the Clinical Efficacy and Safety of Lynparza (Olaparib) Tablets Maintenance Monotherapy in Platinum Sensitive Relapsed...” NCT03534453 ↗10“A capsule formulation of olaparib (tradename Lynparza™) is approved by the United States Food and Drug Administration (FDA) for the treatment of women with advanced...” NCT03432897 ↗ “Olaparib is a PARP inhibitor (poly \[adenosine diphosphate-ribose\] polymerase inhibitor) Other names: Lynparza” NCT05411679 ↗ “The name of the study drug involved in this study is: Olaparib (also known as Lynparza)” NCT05482074 ↗ “Lynparza (Olaparib tablets) 300 mg should be taken orally twice daily” NCT05262608 ↗ “Olaparib [Lynparza®] plus Trastuzumab [Herceptin®]” NCT03931551 ↗ “including olaparib (Lynparza; AstraZeneca)” NCT03561870 ↗ “olaparib (Lynparza®) PARP inhibitor” NCT04999605 ↗ “Olaparib Oral Tablet [Lynparza]” NCT04550104 ↗ “Other Name: Lynparza” NCT04753879 ↗ |
| Known as | NSC-747856 | ChEMBL registry synonym — accepted as the source's own label CHEMBL521686 ↗ |
| Known as | Olaparaib | “Olaparaib: 600 mg/day: 300 mg BID (2 x 150 mg tablets taken orally) each 28 days cycle, until disease progression or unacceptable toxicity” NCT03561870 ↗ |
| Known as | OLAPARIB (AZD2281) | ChEMBL registry synonym — accepted as the source's own label CHEMBL521686 ↗ |
| Known as | Olaparib (NSC 747856) | “Olaparib (NSC 747856)” NCT01623349 ↗ |
| Known as | OLAPARIB COMPONENT OF KEYLYNK-010 | ChEMBL registry synonym — accepted as the source's own label CHEMBL521686 ↗ |
| Known as | Olaparib: also known as Lynparza | “Olaparib: also known as Lynparza” NCT02889900 ↗ |
| Known as | OLAPARIBAZD-2281AZD 2281KU 59436KU-59436LYNPARZAAZD2281KU59436O-9201 | ChEMBL registry synonym — accepted as the source's own label CHEMBL521686 ↗ |
| Action | Inhibit | “poly(ADP-ribose) polymerase (PARP) inhibitor” PMID 20609467 ↗ Jul 2010 |
| Modality | Small molecule | “Olaparib (AZD2281) is a small-molecule, potent oral poly(ADP-ribose) polymerase (PARP) inhibitor.” PMID 21862407 ↗ Aug 2011 |
| Route | Oral | “given orally twice daily” NCT00494234 ↗ |
| Target | PARP1 | “Olaparib is an orally available inhibitor of PARP-1.” PMID 27075016 ↗ Apr 2016 |