Drugs / Ribociclib
Ribociclib
also known as
LEE-011 · Kisqali · RIB · Birociclib · KisqaliTM · LEE-011 SUCCINATE · LEE-011-BBA · LEE-011A · +3 more
Small molecule targets CDK4, CDK6
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed female breast nipple and areola cancer 1 milestone | |||||
| Filed | EU (EMA) | Kisqali | female breast nipple and areola cancer | 2023-10-24 | “Kisqali EU file submission in adjuvant early breast cancer setting” novartis.com ↗ |
| Filed progesterone-receptor positive breast cancer 2 milestones | |||||
| Filed | EU (EMA) | — | progesterone-receptor positive breast cancer | 2016-11-01 | “A Novartis marketing authorization application for LEE011 (ribociclib) plus letrozole has also been accepted for review by the European Medicines Agency (EMA)” astx.com ↗ “the EMA has accepted for review the marketing authorization application for LEE011 plus letrozole in the same patient population” novartis.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2016-11-01 | “the US Food and Drug Administration (FDA) accepted the company's New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib)” astx.com ↗ “FDA accepted the company’s New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib)” astx.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (7) | US (FDA) | KISQALI | — | 2018-07-18 – 2026-07-01 | fda.gov ↗ |
| Approved | EU (EMA) | Kisqali | — | 2017-08-22 | europa.eu ↗ |
| Approved | US (FDA) | KISQALI | — | 2017-03-13 | fda.gov ↗ |
Trials 152 · started per year
today
US approved 2017
EU approved 2017
1
1
8
6
13
21
13
17
11
4
6
13
11
13
8
6
201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06959979 | Nov 2024 → Aug 2026 overdue | childhood medulloblastoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
| Phase 0 | NCT03834740 | Jan 2019 → Feb 2022 | brain glioma, glioblastoma | St. Joseph's Hospital and Medical Center, Phoenix | Completed | No outcome recorded |
| Phase 0 | NCT03179956 | Apr → Nov 2018 | head and neck squamous cell carcinoma | Fox Chase Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT02933736 | Oct 2016 → Mar 2023 overdue | glioblastoma, meningioma | Nader Sanai | Active not recruiting | No outcome recorded |
| Phase 144 trials | ||||||
| Phase 1 | NCT05996107 | Feb 2024 → Oct 2026 expected | female breast carcinoma | University of Michigan Rogel Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05870579 | Nov 2023 → Dec 2026 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05759949 | Mar 2023 → Mar 2025 | PIK3CA-related overgrowth spectrum, hormone receptor-positive breast cancer | Relay Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05429502 | Dec 2022 → Feb 2025 | neuroblastoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT05508906 | Aug 2022 → Dec 2027 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Olema Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05238922 | Jul 2022 → Jul 2027 expected | cancer | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05252416 | Apr 2022 → Jul 2025 | carcinosarcoma, endometrial cancer, esophageal adenocarcinoma, gastric cancer +2 | Blueprint Medicines Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT05216432 | Dec 2021 → Apr 2027 expected | Her2-receptor negative breast cancer, PIK3CA-related overgrowth spectrum | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT04315233 | May 2021 → Mar 2024 | breast cancer, ovarian carcinoma | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04585724 | Jun 2020 → Sep 2021 | female breast carcinoma, metastatic malignant neoplasm in the brain | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04213404 | Mar 2020 → Jan 2024 | head and neck squamous cell carcinoma | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT04000529 | Jul 2019 → Jan 2024 | colorectal cancer, esophageal squamous cell carcinoma, gastrointestinal stromal tumor, head and neck squamous cell carcinoma +1 | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03740334 | Jan 2019 → Mar 2023 overdue | acute lymphoblastic leukemia | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03616587 | Oct 2018 → Sep 2024 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03434262 | Mar 2018 → Sep 2022 | IDH-wildtype glioblastoma, RELA fusion-positive ependymoma, anaplastic ependymoma, anaplastic ganglioglioma +19 | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03333343 | Jan 2018 → Oct 2026 expected | non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03387020 | Jan 2018 → Apr 2020 | atypical teratoid rhabdoid tumor, childhood ependymoma, diffuse intrinsic pontine glioma, medulloblastoma | Pediatric Brain Tumor Consortium | Completed | No outcome recorded |
| Phase 1 | NCT03237390 | Jan 2018 → May 2022 | metastatic malignant neoplasm | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT03355794 | Nov 2017 → Jul 2020 | anaplastic astrocytoma, diffuse intrinsic pontine glioma, glioblastoma | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT03294694 | Nov 2017 → Oct 2020 | hormone receptor-positive breast cancer, malignant epithelial tumor of ovary | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03056833 | Jun 2017 → Jun 2020 | fallopian tube cancer, ovarian cancer, peritoneal carcinoma | Ronald Buckanovich | Completed | No outcome recorded |
| Phase 1 | NCT03009201 | Mar 2017 → Oct 2019 | angiosarcoma, epithelioid sarcoma, fibrosarcoma, leiomyosarcoma +7 | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02974725 | Feb 2017 → Apr 2024 | melanoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02754011 | Feb 2017 → Feb 2022 | breast cancer | UNICANCER | Completed | No outcome recorded |
| Phase 1 | NCT02780128 | Jul 2016 → Aug 2022 | cancer, neuroblastoma | Yael P Mosse | Terminated | No outcome recorded |
| Phase 1 | NCT02703571 | Jun 2016 → Sep 2019 | colorectal cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02734615 | Jun 2016 → Sep 2021 | estrogen-receptor positive breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02345824 | Mar 2016 → Sep 2019 | glioblastoma | University of Virginia | Unknown | No outcome recorded |
| Phase 1 | NCT02586675 | Feb 2016 → May 2017 | female breast carcinoma, male breast carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT02599363 | Jan 2016 → Mar 2019 | female breast carcinoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02431481 | Oct 2015 → Sep 2017 | impaired renal function disease, medulloadrenal hyperfunction | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02370706 | May 2015 → Nov 2020 | myelofibrosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02292550 | May 2015 → Sep 2018 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02414724 | May 2015 → Apr 2016 | lymphoma | Roswell Park Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT02429089 | Apr 2015 → Sep 2017 | head and neck squamous cell carcinoma | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02388620 | Mar 2015 → Jan 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02343172 | Mar 2015 → Oct 2019 | liposarcoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02333370 | Feb 2015 → Sep 2022 | hormone receptor-positive breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02154776 | Jun 2014 → Oct 2016 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02088684 | May 2014 → Apr 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01857193 | Sep 2013 → Mar 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01747876 | May 2013 → Jun 2017 | neuroblastoma, rhabdoid tumor | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01898845 | May 2013 → Jan 2015 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01237236 | Dec 2010 → Mar 2017 | lymphoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/225 trials | ||||||
| Phase 1/2 | NCT07164976 | Oct 2025 → Sep 2029 expected | breast cancer | Nagoya City University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07002177 | Jun 2025 → May 2028 expected | estrogen-receptor positive breast cancer | Forward Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06726148 | Apr 2025 → Sep 2028 expected | hormone receptor-positive breast cancer, small cell lung carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06188520 | Dec 2023 → Aug 2027 expected | estrogen-receptor positive breast cancer, ovarian serous adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05867251 | Aug 2023 → Jan 2028 expected | endometrial cancer, fallopian tube cancer, hormone receptor-positive breast cancer, malignant epithelial tumor of ovary +2 | Avenzo Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05664893 | Jun 2023 → Mar 2026 | Her2-receptor negative breast cancer | Centre Antoine Lacassagne | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05573555 | Mar 2023 → Dec 2026 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05563220 | Jan 2023 → Dec 2026 expected | breast cancer | Stemline Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05358249 | Oct 2022 → Sep 2026 overdue | colorectal carcinoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05319873 | Apr 2022 → Apr 2027 expected | HER2 positive breast carcinoma, invasive breast carcinoma | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04802759 | Jun 2021 → May 2029 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03913234 | Jun 2019 → Oct 2023 | HER2 positive breast carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03090165 | May 2018 → Oct 2026 expected | triple-negative breast carcinoma | Kari Wisinski | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02985125 | May 2017 → Jul 2019 | pancreatic adenocarcinoma | Georgetown University | 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 | NCT02732119 | Jun 2016 → Feb 2020 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02607124 | Apr 2016 → May 2018 | diffuse intrinsic pontine glioma, high grade astrocytic tumor | Children's Hospital Medical Center, Cincinnati | Terminated | No outcome recorded |
| Phase 1/2 | NCT02657343 | Mar 2016 → Aug 2020 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02555189 | Dec 2015 → Dec 2022 | castration-resistant prostate carcinoma, metastatic carcinoma in the bone, metastatic prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Terminated | No outcome recorded |
| Phase 1/2 | NCT02494921 | Nov 2015 → Jul 2021 | prostate cancer | Rahul Aggarwal | Completed | No outcome recorded |
| Phase 1/2 | NCT01872260 | Oct 2013 → Feb 2027 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01777776 | Jul 2013 → Apr 2015 | melanoma | Array BioPharma | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01781572 | Jun 2013 → Jan 2018 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT01543698 | May 2012 → Mar 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 252 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT07423611 | Oct 2026 → Oct 2030 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07826052 | Sep 2026 → Sep 2031 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07527806 | May 2026 → May 2029 expected | breast cancer | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07195227 | Mar 2026 → Feb 2028 expected | hormone receptor-positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT06849947 | Feb 2026 → Jun 2031 expected | breast carcinoma | Yeon Hee Park | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07054190 | Sep 2025 → Jul 2027 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT07037199 | Aug 2025 → Jun 2028 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06953882 | Jul 2025 → Sep 2030 expected | Her2-receptor negative breast cancer | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT07130643 | Dec 2024 → Dec 2026 expected | hormone receptor-positive breast cancer | Xinhong Wu, PhD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05843253 | Aug 2024 → Aug 2029 expected | anaplastic astrocytoma, diffuse glioma, H3 G34 mutant, diffuse midline glioma, H3 K27M-mutant, glioblastoma +2 | Nationwide Children's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06409390 | Aug 2024 → Apr 2027 expected | breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06656624 | Aug 2024 → Dec 2025 overdue | female breast carcinoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06375707 | Jan 2024 → Nov 2025 | breast cancer | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05900206 | Oct 2023 → Apr 2027 expected | breast cancer | Karolinska University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06481956 | Oct 2023 → Jan 2027 expected | HER2 positive breast carcinoma | Zheng Yabing | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06062498 | Sep 2023 → Jul 2028 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Northwestern University | Recruiting | No outcome recorded |
| Phase 2 | NCT05826964 | Jun 2023 → Jul 2026 overdue | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | University of Miami | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05163106 | Dec 2022 → Jul 2024 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, luminal A breast carcinoma +1 | University Hospital, Akershus | Completed | No outcome recorded |
| Phase 2 | NCT05467891 | Sep 2022 → Aug 2028 expected | hormone receptor-positive breast cancer | Oana Danciu | Recruiting | No outcome recorded |
| Phase 2 | NCT05296746 | May 2022 → Oct 2029 expected | breast cancer | SOLTI Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02645149 | Nov 2021 → Nov 2025 | melanoma | Melanoma Institute Australia | Completed | No outcome recorded |
| Phase 2 | NCT04417621 | Oct 2020 → Feb 2027 expected | melanoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04116541 | Jan 2020 → Oct 2026 expected | cancer | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 2 | NCT03283384 | Jun 2019 → Dec 2022 overdue | breast neoplasm | Dutch Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03822468 | Jun 2019 → Jun 2021 | breast cancer | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT04256941 | May 2019 → Sep 2023 | female breast carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03673124 | May 2019 → Dec 2024 overdue | serous neoplasm | Gynecologic Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03839823 | Feb 2019 → Apr 2022 | breast cancer | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03944434 | Dec 2018 → Dec 2024 overdue | breast cancer | Fondazione Sandro Pitigliani | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03484923 | Sep 2018 → Dec 2022 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03671330 | Aug 2018 → Apr 2022 | breast cancer | Novartis Pharmaceuticals | Completed | Mixed |
| Phase 2 | NCT03477396 | Jun 2018 → Sep 2021 | hormone receptor-positive breast cancer | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03555877 | Mar 2018 → Jul 2022 | breast carcinoma | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 2 | NCT03285412 | Dec 2017 → Apr 2026 overdue | breast cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03008408 | Aug 2017 → Aug 2028 expected | endometrial carcinoma, endometrial endometrioid adenocarcinoma, uterine corpus cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03114527 | Aug 2017 → Dec 2026 expected | soft tissue sarcoma | Fox Chase Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03248427 | Jul 2017 → Jun 2019 | breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 2 | NCT03078751 | Jun 2017 → Mar 2020 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03070301 | Feb 2017 → Jan 2024 | neuroendocrine neoplasm | Memorial Sloan Kettering Cancer Center | Completed | Missed primary |
| Phase 2 | NCT02934568 | Dec 2016 → Feb 2027 expected | — | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02657928 | Jul 2016 → May 2018 | estrogen-receptor positive breast cancer, fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma +1 | Mayo Clinic | Completed | Met primary |
| Phase 2 | NCT03096912 | Jul 2016 → Dec 2019 | dedifferentiated liposarcoma, mixed liposarcoma, well-differentiated liposarcoma | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02571829 | May 2016 → Aug 2017 | liposarcoma | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 2 | NCT02524119 | Apr 2016 → Sep 2020 | hepatocellular carcinoma | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT02632045 | Mar 2016 → Jan 2022 | breast carcinoma | Melissa K Accordino | Completed | No outcome recorded |
| Phase 2 | NCT02712723 | Feb 2016 → Aug 2018 overdue | breast cancer | Qamar Khan | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02420691 | Aug 2015 → Jun 2019 | duodenal neuroendocrine tumor, well differentiated, low or intermediate grade, functional pancreatic neuroendocrine tumor, gastric neuroendocrine neoplasm, lung neuroendocrine neoplasm +2 | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02187783 | Aug 2014 → Jan 2018 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02159066 | Jul 2014 → Jan 2023 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02035813 | Jan 2014 → Jan 2024 | hormone receptor-positive breast cancer | University of Ulm | Completed | No outcome recorded |
| Phase 2 | NCT01919229 | Oct 2013 → Sep 2014 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 320 trials · 4 met primary | ||||||
| Phase 3 | NCT07400523 | Feb 2026 → Feb 2030 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT07005557 | Jun 2025 → May 2030 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06377852 | Oct 2024 → Aug 2028 expected | breast cancer | American Society of Clinical Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT06380751 | Aug 2024 → Dec 2029 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06044623 | Apr 2024 → Oct 2028 expected | breast cancer | Region Örebro County | Recruiting | No outcome recorded |
| Phase 3 | NCT05827081 | Feb 2024 → Sep 2029 expected | female breast carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05207709 | Mar 2022 → Mar 2026 | breast cancer | SOLTI Breast Cancer Research Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04862663 | May 2021 → Nov 2027 expected | Her2-receptor negative breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT04055493 | Jul 2019 → Jul 2027 expected | female breast carcinoma | Women's Cancer Study Group GmbH | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03905343 | Jun 2019 → Apr 2021 | breast cancer | Swiss Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03701334 | Dec 2018 → May 2030 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT03462251 | May 2018 → Nov 2021 | hormone receptor-positive breast cancer | iOMEDICO AG | Completed | No outcome recorded |
| Phase 3 | NCT03081234 | Mar 2018 → Nov 2025 | breast cancer | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT03439046 | Feb 2018 → Dec 2023 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT02941926 | Nov 2016 → Nov 2019 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03096847 | Oct 2016 → Dec 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02344472 | Sep 2015 → Jan 2025 | breast cancer | University of Ulm | Unknown | No outcome recorded |
| Phase 3 | NCT02422615 | Jun 2015 → Nov 2017 | breast cancer | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02278120 | Nov 2014 → Aug 2017 | breast cancer | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01958021 | Dec 2013 → Jan 2016 | breast cancer | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT05691400 | Mar 2024 → Mar 2027 | leukodystrophy, hypomyelinating, 22 | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT05452213 | Oct 2022 → Oct 2024 overdue | female breast carcinoma, hormone receptor-positive breast cancer | Institut fuer Frauengesundheit | Recruiting | No outcome recorded |
| Phase 4 | NCT05161195 | Jul 2022 → Jun 2030 expected | metastatic malignant neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05203172 | Jul 2022 → Jul 2029 expected | cancer | Pfizer | Recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06810492 | Apr → Dec 2025 overdue | female breast carcinoma | Hongmei Zheng, PhD | Not yet recruiting | No outcome recorded |
| — | NCT05977036 | Sep 2024 → Sep 2035 expected | breast carcinoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy38 trials | ||||||
| Phase 1 | NCT06625775 Background | Oct 2024 → Nov 2028 expected | HER2 positive breast carcinoma, colorectal cancer, hormone receptor-positive breast cancer, lung carcinoma | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Recruiting | No outcome recorded |
| Phase 1 | NCT06239467 Background | Feb 2024 → Dec 2026 expected | breast cancer | OnKure, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05683418 Background | Feb 2023 → Dec 2027 expected | hormone receptor-positive breast cancer | Totus Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT05384119 Background | Jan 2023 → May 2024 | breast cancer | Tvardi Therapeutics, Incorporated | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02608216 Background | Nov 2015 → Nov 2026 expected | breast cancer | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT07173556 Background | Sep 2025 → Feb 2027 expected | breast cancer | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05768139 Background | Apr 2023 → Jul 2030 expected | breast cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 2 | NCT07618390 Background | Jun 2026 → Dec 2028 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07405801 Background | Apr 2026 → Dec 2028 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT07380646 Background | Jan 2026 → Jan 2028 expected | breast cancer, neutropenia | Second Affiliated Hospital, Zhejiang University, School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07180160 Background | Sep 2025 → Sep 2027 expected | female breast carcinoma | Wenjin Yin | Recruiting | No outcome recorded |
| Phase 2 | NCT06486883 Comparator | Jun 2025 → Jan 2027 expected | hormone receptor-positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT05625087 Comparator | Oct 2023 → Jul 2028 expected | breast cancer | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05816655 Background | May 2023 → Dec 2028 expected | breast cancer | Korea University Guro Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04920708 Comparator | Dec 2022 → Jun 2027 expected | estrogen-receptor positive breast cancer | Royal Marsden NHS Foundation Trust | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05766410 Comparator | Sep 2022 → Sep 2025 overdue | hormone receptor-positive breast cancer | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03227328 Comparator | Aug 2017 → Feb 2022 | hormone receptor-positive breast cancer | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Completed | No outcome recorded |
| Phase 2 | NCT02300987 Comparator | Feb 2015 → Feb 2018 | teratoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT07802626 Comparator | Oct 2026 → Oct 2034 expected | hormone receptor-positive breast cancer | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07391774 Background | Aug 2026 → Jul 2029 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT07340658 Background | Aug 2026 → Feb 2029 expected | breast cancer | Rovi Pharmaceuticals Laboratories | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07647328 Background | Jun 2026 → Feb 2029 expected | breast carcinoma by gene expression profile | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07492641 Comparator | May 2026 → Apr 2029 expected | hormone receptor-positive breast cancer | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06585969 Comparator | Jan 2026 | basal-like breast carcinoma, estrogen-receptor positive breast cancer, luminal B breast carcinoma | Danish Breast Cancer Cooperative Group | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT07174336 Background | Dec 2025 → May 2029 expected | breast neoplasm, metastatic neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07237256 Background | Dec 2025 → Nov 2033 expected | breast cancer | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT07085767 Background | Nov 2025 → Dec 2028 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Olema Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06757634 Comparator | Jul 2025 → Mar 2029 expected | breast cancer | Celcuity Inc | Recruiting | No outcome recorded |
| Phase 3 | NCT06760637 Comparator | Jan 2025 → Jan 2029 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06065748 Background | Dec 2023 → Apr 2028 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05670054 Comparator | Mar 2022 → Oct 2023 | female breast carcinoma | Mansoura University | Unknown | No outcome recorded |
| Phase 3 | NCT04964934 Background | Jun 2021 → Jun 2025 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03425838 Comparator | Nov 2017 → Mar 2023 overdue | breast cancer | Dutch Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03050398 Background | Jun 2017 → Mar 2019 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 4 | NCT07487129 Comparator | Aug 2024 → Oct 2025 | breast cancer | Beni-Suef University | Completed | No outcome recorded |
| Phase 4 | NCT04657679 Comparator | May 2021 → Oct 2023 | breast cancer | Georgetown University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT07706933 Comparator | Aug 2026 → Jun 2028 expected | breast cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05038631 Background | — | breast cancer | Novartis Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 71
| Date | Issuer | Release |
|---|---|---|
| 2026-09-04 | Alexion Pharmaceuticals, Inc. | Regulatory Etcamah in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer astrazeneca.com ↗ |
| 2026-07-23 | AstraZeneca | Regulatory Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1st-line advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2026-06-02 | AstraZeneca | Results Camizestrant combination delayed time to first progression by 55% and to second progression by 37% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 trial astrazeneca.com ↗
Median PFS2 was 25.7 months for the camizestrant combination compared with 19.1 months for the AI combination. |
| 2026-05-22 | AstraZeneca | Regulatory Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2025-12-09 | Novartis Pharmaceuticals | Results 1 in 4 metastatic breast cancer patients treated with Novartis Kisqali® remain progression-free beyond 4 years novartis.com ↗
Long-term progression-free survival benefit with Kisqali was observed in patients regardless of their menopausal status and was achieved even in a proportion of patients with unfavorable prognostic factors (liver involvement, ≥ 3 metastatic sites) 1 . |
| 2025-11-25 | Novartis Pharmaceuticals | Results Novartis data underscore pioneering scientific innovation in hematology and oncology at ASH and SABCS novartis.com ↗
Kisqali NATALEE and MONALEESA data add to evidence of long-term benefits for early and metastatic breast cancer patients |
| 2025-10-30 | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Results BBOT Announces Poster Presentations at the San Antonio Breast Cancer Symposium (SABCS) bbotx.com ↗
BBO-10203, a first-in-class breaker of the RAS:PI3Kα interaction, inhibits tumor growth alone and in combination with fulvestrant or ribociclib in breast cancer models without inducing hyperglycemia |
| 2025-10-17 | Novartis Pharmaceuticals | Results Novartis Kisqali® 5-year NATALEE data demonstrate 28% reduction in risk of recurrence in the broadest early breast cancer patient population novartis.com ↗ |
| 2025-07-17 | Novartis Pharmaceuticals | Results Novartis reports strong Q2 with double-digit sales growth and core margin expansion; raises FY 2025 core operating income guidance novartis.com ↗
A new subgroup analysis of the Phase III NATALEE trial in HR+/HER2- early breast cancer (eBC) showed that patients receiving Kisqali plus endocrine therapy continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status, at median follow-up of 44.2 months. |
| 2025-06-01 | Novartis Pharmaceuticals | Results Novartis Kisqali® reduces risk of recurrence in younger patients with early breast cancer in NATALEE subgroup analysis novartis.com ↗ |
| 2025-06-01 | AstraZeneca | Results Camizestrant reduced the risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial astrazeneca.com ↗
Results showed the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.31–0.60; p<0.00001) as assessed by investigator. |
| 2025-05-22 | Menarini Group | Results Menarini Group Presents Updated Data Underscoring the Combinability of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2025 Annual Meeting menarini.com ↗
ELEVATE results reported at ASCO 2025 (abstract 1070/49) include updated efficacy data which demonstrate favorable preliminary progression-free survival (PFS) from the elacestrant plus ribociclib and the elacestrant plus everolimus cohorts. |
| 2025-02-26 | AstraZeneca | Results Camizestrant demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival in 1st-line advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial astrazeneca.com ↗ |
| 2024-12-10 | Novartis Pharmaceuticals | Results Longer-term Novartis Kisqali® NATALEE data show durable reduction in distant recurrence in broad population of patients with early breast cancer novartis.com ↗
Results showed a sustained reduction in distant recurrence of 28.5% (HR=0.715; 95% CI 0.604-0.847; nominal P<0.0001), compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) 1 . |
| 2024-11-27 | Novartis Pharmaceuticals | Regulatory Novartis Kisqali® receives European Commission approval in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence novartis.com ↗ |
| 2024-10-18 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer novartis.com ↗ |
| 2024-09-17 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer novartis.com ↗
Novartis today announced that the US Food and Drug Administration (FDA) has approved Kisqali ® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease 1 . |
| 2024-09-16 | Novartis Pharmaceuticals | Results Novartis Kisqali® shows deepening benefit in new analysis, reducing the risk of recurrence by 28.5% in a broad population of patients with early breast cancer novartis.com ↗
Invasive disease-free survival benefit continued to increase after completion of the three-year treatment period across all patient subgroups, including those with node-negative disease |
| 2024-07-18 | The Medicines Company | Results Novartis a poursuivi au T2 la forte croissance de son chiffre d’affaires et l’expansion de sa marge core; hausse des prévisions de son résultat opérationnel core pour 2024 novartis.com ↗ |
| 2024-05-31 | Novartis Pharmaceuticals | Results Latest analysis of Novartis NATALEE study shows Kisqali® reduces risk of cancer recurrence for early breast cancer patients with high-risk node-negative disease novartis.com ↗
The latest analysis demonstrated that Kisqali ® (ribociclib) plus endocrine therapy (ET), compared to ET alone, showed an improvement in rates of invasive disease-free survival (iDFS), distant recurrence-free survival (DRFS), and distant disease-free survival (DDFS) in high-risk EBC patients with N0 disease 1,2 . |
| 2024-05-24 | Menarini Group | Results Menarini Group Presents Updated Data from ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2024 Annual Meeting menarini.com ↗
Updated analysis from the ELEVATE study demonstrates that all evaluable elacestrant plus targeted therapy combination arms are consistent with the known safety profiles of everolimus, alpelisib, ribociclib and palbociclib plus standard of care endocrine therapy. |
| 2024-05-23 | Blueprint Medicines Corporation | Results Blueprint Medicines to Present the First Promising and Most Advanced Clinical Data for a CDK2 Inhibitor in Combination with an Approved CDK4/6 Inhibitor in HR+/HER2- Breast Cancer at the 2024 ASCO Annual Meeting blueprintmedicines.com ↗ |
| 2024-04-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approvals For the Qtr ended 31st Mar, 2024 alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals receives one US Food & Drug Administration (USFDA) product approval (Tentative) during the quarter ended 31st March, 2024. |
| 2023-12-11 | Menarini Group | Results Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium menarini.com ↗
A preliminary analysis of data in the phase 1b part of the ELEVATE trial demonstrates antitumor activity of the combination evaluating ORSERDU with inhibitors of the PI3K/AKT/mTOR pathway and CDK 4/6 inhibitors. |
| 2023-12-08 | Novartis Pharmaceuticals | Results Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions novartis.com ↗
Basel, December 8, 2023 – Novartis today announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali ® (ribociclib) treatment completion by 78.3% of patients. |
| 2023-10-20 | Novartis Pharmaceuticals | Results Novartis Kisqali® NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancer novartis.com ↗
After 27.7 months of follow-up, the iDFS benefit with Kisqali ® (ribociclib) plus endocrine therapy (ET) was consistent across key prespecified subgroups, compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) (see table below) 1 . |
| 2023-10-05 | Novartis Pharmaceuticals | Results Novartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer novartis.com ↗
New analysis of key subgroups of clinical interest from NATALEE reinforces the potential of Kisqali ® (ribociclib) plus endocrine therapy (ET) to consistently reduce the risk of cancer recurrence |
| 2023-09-14 | Novartis Pharmaceuticals | Results Novartis Kisqali® reduced the risk of cancer recurrence while maintaining quality of life in patients diagnosed with early breast cancer novartis.com ↗
Patient-reported outcomes (PROs) from the Phase III NATALEE trial show that patients receiving adjuvant Kisqali plus endocrine therapy (ET) for up to three years maintained physical and social functioning; psychological well-being; and overall health scores, compared to baseline 1 |
| 2023-06-02 | Novartis Pharmaceuticals | Results Novartis Kisqali® significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful benefit was consistent across subgroups novartis.com ↗
Kisqali is the first and only CDK4/6 inhibitor to demonstrate a consistent, clinically meaningful benefit across a broad population of patients with HR+/HER2- early breast cancer, regardless of disease stage, menopausal or nodal status |
| 2023-03-27 | Novartis Pharmaceuticals | Results Novartis Kisqali® Phase III NATALEE trial meets primary endpoint at interim analysis demonstrating clinically meaningful benefit in broad population of patients with early breast cancer novartis.com ↗
Kisqali plus ET significantly reduced the risk of disease recurrence, compared to standard adjuvant ET alone, with consistent benefit in patients with stage II and stage III EBC regardless of nodal involvement 1 . |
| 2022-12-06 | Novartis Pharmaceuticals | Results Novartis Kisqali® prolonged PFS benefit for pre- and perimenopausal patients with aggressive HR+/HER2− metastatic breast cancer compared to chemotherapy novartis.com ↗
Kisqali demonstrated a nearly one-year progression-free survival (PFS) benefit in the study, supporting the superiority of Kisqali plus ET for this hard-to-treat patient population. |
| 2022-09-09 | Novartis Pharmaceuticals | Results Novartis Kisqali® adds one more year of survival benefit for broadest set of patients, including those with aggressive HR+/HER2- advanced breast cancer novartis.com ↗
Kisqali plus endocrine therapy reports a median OS of approximately five years in patients with visceral metastases, adding a nearly one-year survival benefit compared to ET alone in this harder-to-treat population 1 |
| 2022-08-30 | Novartis Pharmaceuticals | Results Novartis presents new data in breast and prostate cancer at ESMO novartis.com ↗
Overall survival results from pooled exploratory analysis of MONALEESA trials in patients with aggressive HR+/HER2- advanced breast cancer treated with Kisqali ® |
| 2022-06-03 | Novartis Pharmaceuticals | Results New CDK4/6i data at ASCO reinforce Novartis Kisqali® as only drug in class with consistently proven overall survival benefit in HR+/HER2- metastatic breast cancer novartis.com ↗ |
| 2022-05-04 | Novartis Pharmaceuticals | Results New Novartis data demonstrate only Kisqali® offers more life in the first-line setting for postmenopausal HR+/HER2- advanced breast cancer patients novartis.com ↗
Novartis today announced updated median overall survival (OS) results for Kisqali ® (ribociclib) in combination with fulvestrant in the first-line subgroup of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. |
| 2022-03-10 | Novartis Pharmaceuticals | Results NEJM publication of Novartis Kisqali® data shows longest median overall survival ever reported in HR+/HER2- advanced breast cancer novartis.com ↗
Basel, March 9, 2022 — Novartis today announced that The New England Journal of Medicine (NEJM) published data showing the Phase III MONALEESA-2 trial for Kisqali ® (ribociclib) plus letrozole demonstrated a statistically significant improvement in overall survival. |
| 2021-12-08 | Novartis Pharmaceuticals | Results New Kisqali® data shows consistent overall survival benefit across genomic and clinical subtypes of interest in HR+/HER2- metastatic breast cancer novartis.com ↗
Kisqali pooled data at the San Antonio Breast Cancer Symposium confirms OS benefit across most common genomic intrinsic subtypes of HR+/HER2- metastatic breast cancer, including the aggressive, ET-resistant HER2-enriched subtype 6 |
| 2021-09-19 | Novartis Pharmaceuticals | Results Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer novartis.com ↗
Kisqali in combination with letrozole met its key secondary endpoint of OS, demonstrating a statistically significant and clinically meaningful improvement in survival (median 63.9 vs. 51.4 months; HR=0.76; 95% CI: 0.63-0.93; p=0.004) 2 . |
| 2021-06-02 | Novartis Pharmaceuticals | Results Novartis Kisqali® reports longest median overall survival in postmenopausal HR+/HER2- metastatic breast cancer patients novartis.com ↗ |
| 2020-12-09 | Novartis Pharmaceuticals | Results Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer novartis.com ↗
After a median of 53.5 months follow-up, median OS for patients taking Kisqali in combination with endocrine therapy was 58.7 months vs. 48.0 months for endocrine therapy alone (HR=0.76 [95% CI: 0.61-0.96]) 1 . |
| 2020-12-09 | Novartis Pharmaceuticals | Results Novartis Kisqali® data demonstrate superior benefit across main intrinsic subtypes in metastatic breast cancer novartis.com ↗
Novartis today announced new Kisqali ® (ribociclib) data demonstrating consistent efficacy benefit with Kisqali plus endocrine therapy across the main intrinsic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer. |
| 2020-09-21 | Novartis Pharmaceuticals | Results Novartis Kisqali® receives the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale novartis.com ↗
A trend toward improved progression free survival (PFS) for Kisqali plus fulvestrant versus palbociclib plus letrozole was also observed. |
| 2020-05-27 | Novartis Pharmaceuticals | Results Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease novartis.com ↗ |
| 2019-12-12 | Novartis Pharmaceuticals | Results Novartis Kisqali® data show superior overall survival compared to fulvestrant and consistent efficacy across advanced breast cancer patient subgroups in MONALEESA-3 novartis.com ↗
The NEJM publication includes new analyses confirming overall survival benefit across all patient sub-groups treated with Kisqali plus fulvestrant. |
| 2019-09-29 | Novartis Pharmaceuticals | Results Novartis Kisqali® delivers consistently superior overall survival – MONALEESA-3 trial demonstrates more life for postmenopausal HR+/HER2- advanced breast cancer patients novartis.com ↗
In MONALEESA-3, Kisqali plus fulvestrant achieved statistically significant overall survival benefit vs. fulvestrant alone in postmenopausal women (HR=0.724; p=0.00455) |
| 2019-07-31 | Novartis Pharmaceuticals | Results Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials novartis.com ↗
Novartis today announced Kisqali ® (ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial. |
| 2019-06-07 | Astex Pharmaceuticals, Inc. | Results British Company Behind Groundbreaking Breast Cancer Treatment astx.com ↗
Astex welcomes positive, new data showing breast cancer drug, Kisqali® (ribociclib), cuts risk of death by up to a third when given with hormone therapy |
| 2019-06-01 | Novartis Pharmaceuticals | Results Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial novartis.com ↗
Novartis today announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy[1]. |
| 2018-12-21 | Novartis Pharmaceuticals | Regulatory Novartis receives European Commission (EC) approval for expanded indication for Kisqali® (ribociclib) novartis.com ↗
Novartis today announced that the European Commission (EC) approved an expanded indication for Kisqali ® (ribociclib), the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent and sustained efficacy compared to endocrine therapy alone. |
| 2018-12-08 | Novartis Pharmaceuticals | Results Novartis data demonstrates consistent efficacy and tolerability of Kisqali® combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease novartis.com ↗
Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine therapy alone; consistent with the overall study populations |
| 2018-11-16 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion to expand Kisqali® combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer novartis.com ↗
This positive CHMP opinion is based on data from the Phase III MONALEESA-7 and MONALEESA-3 trials. |
| 2018-07-18 | Novartis Pharmaceuticals | Regulatory Novartis Kisqali® now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for premenopausal women; and as initial therapy with fulvestrant in postmenopausal women novartis.com ↗
Basel, July 18, 2018 - Novartis today announced a new approval for Kisqali ® (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. |
| 2018-06-03 | Novartis Pharmaceuticals | Results Third Novartis Phase III trial shows Kisqali® combination therapy significantly improves PFS in HR+/HER2- advanced breast cancer novartis.com ↗
MONALEESA-3 showed Kisqali plus fulvestrant significantly prolonged progression-free survival (PFS) compared to fulvestrant alone in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer. |
| 2018-01-03 | Novartis Pharmaceuticals | Regulatory Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer novartis.com ↗
Novartis today announced Kisqali ® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor. |
| 2017-12-06 | Novartis Pharmaceuticals | Results Kisqali® first and only CDK4/6 inhibitor to show superior efficacy vs. oral endocrine therapy as 1L treatment in randomized Phase III trial in premenopausal women with HR+/HER2- advanced breast cancer novartis.com ↗
Kisqali plus an oral endocrine partner demonstrated significant efficacy with sustained benefit of nearly two years (median PFS 23.8 vs 13.0 months for endocrine therapy alone) and an early response with separation of the PFS curves as early as eight weeks[1] |
| 2017-11-08 | Novartis Pharmaceuticals | Results Novartis reports positive results from Phase III trial of Kisqali® (ribociclib) combination therapy in premenopausal women with HR+/HER2- advanced or metastatic breast cancer novartis.com ↗
Novartis today announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali ® (ribociclib) in advanced or metastatic breast cancer. |
| 2017-08-24 | Novartis Pharmaceuticals | Regulatory Novartis Kisqali® (ribociclib) receives EU approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor novartis.com ↗ |
| 2017-08-24 | Astex Pharmaceuticals, Inc. | Regulatory Astex Pharmaceuticals Celebrates as Cancer Drug Receives Marketing Approval in Europe astx.com ↗
Approval by the European Commission follows a positive opinion granted in June by the Committee for Medicinal Products for Human Use (CHMP). |
| 2017-06-23 | Novartis Pharmaceuticals | Regulatory Novartis Kisqali® (ribociclib) receives positive CHMP opinion as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor novartis.com ↗ |
| 2017-06-02 | Novartis Pharmaceuticals | Results Novartis presents updated data that reinforce the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a first-line option for HR+/HER2- advanced or metastatic breast cancer novartis.com ↗
After an additional 11 months of follow-up, a median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) for Kisqali plus letrozole and 16.0 months (95% CI: 13.4-18.2) for letrozole alone was observed (HR=0.568 (95% CI: 0.457-0.704; p<0.0001))[1]. |
| 2017-03-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Ribociclib (LEE011) Receives Regulatory Approval in U.S. as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer with an aromatase inhibitor otsuka.co.jp ↗
Manufacturing and marketing approval was granted to Novartis for use of the drug as a first-line treatment in combination with an aromatase inhibitor for patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer. |
| 2017-03-13 | Novartis Pharmaceuticals | Regulatory Novartis Kisqali® (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor novartis.com ↗
Kisqali was reviewed and approved under the FDA Breakthrough Therapy designation and Priority Review programs. |
| 2017-03-13 | Astex Pharmaceuticals, Inc. | Regulatory Cambridge-based Astex Pharmaceuticals Celebrates as Cancer Drug Receives US Marketing Approval astx.com ↗
Novartis drug Kisqali ® (ribociclib, LEE011) receives marketing approval by the US FDA as a first-line drug for HR+/HER2- advanced breast cancer in combination with an aromatase inhibitor |
| 2016-12-09 | Novartis Pharmaceuticals | Results Novartis LEE011 (ribociclib) plus letrozole analyses show superior PFS across broad spectrum of patients in first-line HR+/HER2- advanced breast cancer versus letrozole novartis.com ↗
These findings demonstrate the strength of LEE011 plus letrozole in the first-line setting, showing that treatment benefit was evident across all patient subgroups regardless of their disease burden or tumor location, including those patients with aggressive disease. |
| 2016-11-01 | Novartis Pharmaceuticals | Regulatory Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2016-11-01 | Astex Pharmaceuticals, Inc. | Regulatory Astex Achieves Milestone on US FDA Filing of New Drug Application (NDA) for LEE011 (ribociclib) plus letrozole as a first-line treatment for HR+/HER2- Advanced Breast Cancer astx.com ↗
Separately, Novartis announced today that the US Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib) |
| 2016-10-20 | Astex Pharmaceuticals, Inc. | Results Positive Phase III Clinical Trial Results for Ribociclib (LEE011), an Investigational Compound for Advanced Breast Cancer in Development by Major Pharmaceutical Company under a Research Collaboration with Otsuka’s Subsidiary Astex Pharmaceuticals astx.com ↗
Positive clinical trial results on ribociclib (LEE011) plus letrozole as first-line treatment for advanced or metastatic breast cancer, compared to letrozole alone, were presented by Novartis at the European Society for Medical Oncology (ESMO) 2016. |
| 2016-10-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Positive Phase III Clinical Trial Results for Ribociclib (LEE011), an Investigational Compound for Advanced Breast Cancer in Development by Major Pharmaceutical Company under a Research Collaboration with Otsuka's Subsidiary Astex Pharmaceuticals otsuka.co.jp ↗
Progression-free survival (the length of time during which cancer does not progress) was significantly extended in the experimental group treated with ribociclib plus letrozole. |
| 2016-10-08 | Novartis Pharmaceuticals | Results Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care novartis.com ↗
LEE011 (ribociclib) plus letrozole reduced the risk of progression or death by 44% over letrozole alone, significantly extending progression-free survival (PFS) across all patient subgroups |
| 2016-08-03 | Novartis Pharmaceuticals | Regulatory Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy designation as first-line treatment for HR+/HER2- advanced breast cancer novartis.com ↗
Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. |
| 2016-05-18 | Novartis Pharmaceuticals | Results MONALEESA-2 trial of Novartis' LEE011 (ribociclib) stopped due to positive efficacy results at interim analysis in HR+/HER2- advanced breast cancer novartis.com ↗
LEE011 (ribociclib), a CDK4/6 inhibitor, in combination with letrozole, showed clinically meaningful improvement in PFS in postmenopausal women who had received no prior therapy for advanced breast cancer[1] |
All press releases naming this drug 77 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 193 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ribociclib | “This was a multi-center, randomized, double blind (investigator and subject), placebo controlled Phase II study to determine the efficacy and safety of treatment with...” NCT02300987 ↗165“An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib...” NCT02934568 ↗ “Full initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or...” NCT06044623 ↗ “Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive,...” NCT05670054 ↗ “sequential Trastuzumab rezetecan followed by CDK4/6 inhibitors (Dalpiciclib, Abemaciclib, Ribociclib, Palbociclib) plus endocrine therapy” NCT07037199 ↗ “CDK4/6 Inhibitor (Palbociclib or Ribociclib): Dosed per standard practice, Days 1-21 of every cycle x 4 cycles” NCT07802626 ↗ “physician's choice of CDK4/6 inhibitor (CDK4/6i) including palbociclib, ribociclib, and abemaciclib” NCT06486883 ↗ “All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)” NCT07005557 ↗ “ribociclib at the standard dose (orally, 400mg, once daily on days 1-21 of a 28-day cycle)” NCT07380646 ↗ “CDK4/6 inhibitors：dalpiciclib,palbociclib,abemaciclib,ribociclib” NCT07130643 ↗ “CDK4/6 inhibitor: * palbociclib * ribociclib * abemaciclib” NCT03227328 ↗ |
| Known as | Birociclib | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | Kisqali | “provide access to ribociclib (LEE011, Kisqali®), for locally advanced or metastatic cancer resistant or refractory to available treatment options and candidate for therapy with...” NCT05038631 ↗2“Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI®” NCT06757634 ↗ “Leucogen combined with Ribociclib (Kisqali®) and Endocrine Therapy (e.g., Letrozole, Anastrozol)” NCT07380646 ↗ |
| Known as | KisqaliTM | “Patients entered into this study will be given letrozole (FemarTM) in combination with ribociclib (KisqaliTM) for at least 6 months.” NCT05163106 ↗ |
| Known as | LEE-011 | “Preclinical studies with ribociclib (LEE-011), a CDK4/6 cell cycle checkpoint inhibitor, demonstrate a synergistic effect with platinum chemotherapy and efficacy as a...” PMID 35972817 ↗ Sep 202230“A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection” NCT03834740 ↗ “Ribociclib (formerly LEE011) is an orally bioavailable, highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).” NCT03673124 ↗ “Treatment of CDK4/6 Therapy/LEE011/Ribociclib” NCT03050398 ↗ “LEE011 (Ribociclib)” NCT02494921 ↗ “Ribociclib (LEE011)” NCT02599363 ↗ “ribociclib (LEE011)” NCT01857193 ↗ |
| Known as | LEE-011 SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | LEE-011-BBA | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | LEE-011A | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | NVP-LEE011 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | RIB | “The phase 3 MONALEESA-2 study demonstrated that addition of ribociclib (RIB) to letrozole (LET) significantly improved progression-free survival (PFS) in patients (pts) with...” PMID 29404806 ↗ Feb 20181“Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive,...” NCT05670054 ↗ |
| Known as | Ribociclib Succinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07391774 ↗ |
| Known as | Ribociclib succinate component of kisqali femara co-pack | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Action | Inhibit | “designed to inhibit the activity of an enzyme known as CDK4/6” NCT01237236 ↗ |
| Modality | Small molecule | “LEE011 is a small molecule inhibitor of CDK4/6.” NCT01747876 ↗ |
| Route | Oral | “LEE011 is a new oral drug” NCT01237236 ↗ |
| Target | CDK4 | “LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6.” NCT01237236 ↗ |