Drugs / Trastuzumab deruxtecan
Trastuzumab deruxtecan
also known as
T-DXd · DS-8201a · DS-8201 · fam-trastuzumab deruxtecan-nxki · ENHERTU · DS-8201a (T-DXd) · DS-8201a (trastuzumab derextecan) · DS-8210 · +2 more
Monoclonal antibody targets ERBB2
Regulatory milestones approvals, filings & regulatory actions · 25 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed female breast nipple and areola cancer 5 milestones | |||||
| Filed | US (FDA) | Enhertu | female breast nipple and areola cancer | 2026-03-09 | “supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US” astrazeneca.com ↗ “an sBLA for Enhertu followed by paclitaxel, trastuzumab and pertuzumab (THP) currently is under review in the US” astrazeneca.com ↗ |
| Filed | US (FDA) | — | female breast nipple and areola cancer | 2019-10-17 | “the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201)” daiichisankyo.com ↗ “the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201)” astrazeneca.com ↗ |
| Filed | Japan (PMDA) | Enhertu | female breast nipple and areola cancer | — | “trastuzumab deruxtecan was recently made to Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with HER2-positive metastatic breast cancer.” astrazeneca.com ↗ “[fam-] trastuzumab deruxtecan was recently made to Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of HER2 positive breast cancer.” daiichisankyo.com ↗ “A regulatory submission to the Japan MHLW for DS-8201 for the treatment of HER2 positive metastatic breast occurred in September 2019” daiichisankyo.com ↗ “Regulatory submissions for Enhertu based upon DESTINY-Breast05 are also under review in the EU and Japan.” astrazeneca.com ↗ |
| Filed | Other | Enhertu | female breast nipple and areola cancer | — | “the Enhertu plus pertuzumab 1st-line regimen is under review by Switzerland’s Swissmedic (SMC)” astrazeneca.com ↗ |
| Filed | EU (EMA) | Enhertu | female breast nipple and areola cancer | — | “Additional regulatory submissions for Enhertu are under review in the EU, including in combination with pertuzumab for the 1st-line treatment” astrazeneca.com ↗ “Regulatory submissions for Enhertu based upon DESTINY-Breast05 are also under review in the EU and Japan.” astrazeneca.com ↗ “Additional regulatory submissions for Enhertu are under review in the EU” astrazeneca.com ↗ |
| Filed gastroesophageal adenocarcinoma 1 milestone | |||||
| Filed | Japan (PMDA) | ENHERTU | gastroesophageal adenocarcinoma | 2020-05-07 | “Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in Japan for Treatment of Patients with HER2 Positive Metastatic Gastric Cancer” daiichisankyo.com ↗ “a supplemental New Drug Application (NDA) was submitted to the Japan Ministry of Health, Labour and Welfare (MHLW) for approval in April 2020.” daiichisankyo.com ↗ |
| Filed Her2-receptor negative breast cancer 7 milestones | |||||
| Filed | US (FDA) | Enhertu | Her2-receptor negative breast cancer | 2025-09-24 | “sBLA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been accepted and granted Priority Review in the US” astrazeneca.com ↗ |
| Filed | US (FDA) | Enhertu | Her2-receptor negative breast cancer | 2024-01-29 | “AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US” astrazeneca.com ↗ |
| Filed | US (FDA) | Enhertu | Her2-receptor negative breast cancer | 2022-07-25 | “received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu” astrazeneca.com ↗ |
| Filed | US (FDA) | Enhertu | Her2-receptor negative breast cancer | 2022-04-19 | “AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu” astrazeneca.com ↗ |
| Filed | US (FDA) | Enhertu | Her2-receptor negative breast cancer | 2022-01-17 | “A supplemental Biologics License Application for Enhertu followed by THP based on the results from DESTINY-Breast11 is currently under review” astrazeneca.com ↗ “AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu” astrazeneca.com ↗ |
| Filed | EU (EMA) | Enhertu | Her2-receptor negative breast cancer | 2020-07-07 | “today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan” daiichisankyo.com ↗ “Regulatory applications for Enhertu are currently under review in Europe” astrazeneca.com ↗ “Enhertu also is currently under review in Europe” astrazeneca.com ↗ |
| Filed | Japan (PMDA) | Enhertu | Her2-receptor negative breast cancer | — | “Regulatory applications for Enhertu are currently under review in Europe, Japan” astrazeneca.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (9) | US (FDA) | ENHERTU | — | 2021-01-15 – 2026-04-27 | fda.gov ↗ |
| Filed | US (FDA) | Enhertu | HER2-low, HER2-ultralow breast cancer | 2024-10-01 | “AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US” astrazeneca.com ↗ |
| Approved · conditional | EU (EMA) | Enhertu | — | 2021-01-18 | europa.eu ↗ |
| Approved | US (FDA) | ENHERTU | — | 2019-12-20 | fda.gov ↗ |
Trials 141 · started per year
today
US approved 2019
EU approved 2021
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 121 trials · 1 met primary | ||||||
| Phase 1 | NCT07454668 | Jan 2027 → Feb 2029 expected | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Baptist Health South Florida | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07137416 | Oct 2026 → Jan 2028 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT07553390 | Oct 2026 → Mar 2036 expected | breast cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07015697 | Jul 2025 → Dec 2028 expected | — | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1 | NCT06364410 | Feb 2025 → Jul 2027 expected | gastric carcinoma, gastroesophageal junction adenocarcinoma, metastatic malignant neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT06331169 | Jul 2024 → Dec 2026 expected | breast cancer | Fudan University | 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 | NCT05650879 | Mar 2023 → Jul 2026 overdue | HER2 positive breast carcinoma, lung cancer | Enliven Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05633979 | Feb 2023 → Dec 2030 expected | breast cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05372614 | Oct 2022 → Jul 2028 expected | metastatic malignant neoplasm, pancreatic adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05274048 | Jun 2022 → Jun 2027 expected | gastric cancer | Fox Chase Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04704661 | Aug 2021 → Mar 2027 expected | HER2 positive breast carcinoma, colon carcinoma, endometrial carcinoma, female breast carcinoma +6 | National Cancer Institute (NCI) | Active not 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 | NCT04556773 | Dec 2020 → Aug 2023 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04294628 | Sep 2020 → Sep 2025 overdue | metastatic malignant neoplasm, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04042701 | Feb 2020 → Jul 2025 overdue | breast cancer, non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03523572 | Aug 2018 → Jul 2021 | breast cancer, urothelial carcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03368196 | Apr → Sep 2018 | breast neoplasm, gastric adenocarcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03383692 | Jan → Sep 2018 | metastatic malignant neoplasm | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03366428 | Dec 2017 → Dec 2018 | breast cancer | Daiichi Sankyo | Completed | Met primary |
| Phase 1 | NCT02564900 | Sep 2015 → Feb 2019 | cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1/217 trials · 1 missed | ||||||
| Phase 1/2 | NCT07619521 | Jun 2027 → Sep 2028 expected | pancreatic ductal adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07701941 | Sep 2026 → Jan 2031 expected | hormone receptor-positive breast cancer | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07012031 | Jun 2026 → Jun 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07198724 | Nov 2025 → Jun 2028 expected | Her2-receptor negative breast cancer, female breast carcinoma | Kristina A. Fanucci | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06731803 | Mar 2025 → Dec 2027 expected | gastroesophageal adenocarcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06085755 | Sep 2024 → Dec 2025 overdue | gastric neoplasm | Jeeyun Lee | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06525298 | Sep 2024 → Sep 2027 expected | neoplasm | Eisbach Bio GmbH | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06328387 | Jan 2024 → Feb 2026 | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 1/2 | NCT07529613 | Dec 2023 → Dec 2025 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | National Cancer Center Hospital East | Completed | No outcome recorded |
| Phase 1/2 | NCT05824975 | May 2023 → Nov 2025 overdue | Her2-receptor negative breast cancer, colorectal cancer, cutaneous melanoma, hepatocellular carcinoma +3 | GI Innovation, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05868226 | Feb 2023 → Dec 2030 expected | HER2 positive breast carcinoma, colon adenocarcinoma, hormone receptor-positive breast cancer, metastatic malignant neoplasm +2 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05417594 | Jun 2022 → Feb 2028 expected | high grade malignant neoplasm | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05091528 | Feb → Jul 2022 | HER2 positive breast carcinoma, non-small cell lung carcinoma | Silverback Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04538742 | Dec 2020 → Jan 2025 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04644068 | Nov 2020 → May 2027 expected | biliary tract cancer, breast cancer, cervical cancer, colorectal cancer +8 | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03742102 | Dec 2018 → Nov 2024 overdue | triple-negative breast carcinoma | AstraZeneca | Active not recruiting | Missed primary |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 276 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT07126561 | Nov 2026 → Nov 2028 expected | carcinoma | University of Chicago | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07619365 | Oct 2026 → Oct 2030 expected | breast cancer | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07836257 | Oct 2026 → Oct 2028 expected | breast cancer | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07691489 | Oct 2026 → Jun 2029 expected | colon adenocarcinoma, rectum adenocarcinoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07825753 | Sep 2026 → Sep 2027 expected | breast cancer, pancreatic adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07662473 | Jul 2026 → Dec 2027 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | 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 | NCT07497386 | Apr 2026 → Jun 2028 expected | breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07647016 | Apr 2026 → Dec 2027 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07459673 | Mar 2026 → Mar 2030 expected | HER2 positive breast carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07371585 | Feb 2026 → Aug 2029 expected | breast cancer | SOLTI Breast Cancer Research Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07428044 | Feb 2026 → Feb 2027 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07393425 | Feb 2026 → Sep 2027 expected | HER2 positive breast carcinoma | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07368543 | Jan 2026 → Jun 2027 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07407465 | Oct 2025 → Oct 2027 expected | colon adenocarcinoma, rectum adenocarcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT07150208 | Oct 2025 → Sep 2027 expected | breast carcinoma by gene expression profile | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07151586 | Oct 2025 → Oct 2029 expected | metastatic malignant neoplasm, triple-negative breast carcinoma | UNICANCER | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07152782 | Sep 2025 → Aug 2029 expected | HER2 positive breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06680596 | Jul 2025 → Aug 2028 expected | breast carcinoma | UNICANCER | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07069712 | Jul 2025 → Nov 2027 expected | gastroesophageal adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT07657130 | Jul 2025 → Jun 2026 overdue | female breast carcinoma | Liaoning Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06486883 | Jun 2025 → Jan 2027 expected | hormone receptor-positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT06750484 | Jun 2025 → Dec 2028 expected | breast cancer | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT06832202 | Apr 2025 → Jun 2027 expected | hormone receptor-positive breast cancer | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06311214 | Mar 2025 → Mar 2028 expected | metastatic malignant neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06610825 | Mar 2025 → Oct 2027 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Washington D.C. Veterans Affairs Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06797622 | Feb 2025 → Jan 2027 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06450314 | Jan 2025 → Dec 2027 expected | HER2 positive breast carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT06630130 | Jan 2025 → Oct 2028 expected | gastric cancer | Jeeyun Lee | Recruiting | No outcome recorded |
| Phase 2 | NCT06733233 | Jan 2025 → Jan 2028 expected | estrogen-receptor positive breast cancer | Guangzhou Women and Children's Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06533826 | Oct 2024 → Jan 2028 expected | Her2-receptor negative breast cancer | Ana C Garrido-Castro, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06548178 | Sep 2024 → Sep 2025 overdue | HER2 positive breast carcinoma | Fudan University | Not yet 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 | NCT06439693 | Aug 2024 → Mar 2030 expected | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer, female breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06172127 | Jul 2024 → Apr 2027 expected | HER2 positive breast carcinoma | MedSIR | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06250777 | Jul 2024 → Dec 2026 expected | non-small cell lung carcinoma | Yonsei University | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06048718 | Jun 2024 → Nov 2026 expected | breast cancer | MedSIR | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05982678 | May 2024 → Oct 2027 expected | HER2 positive breast carcinoma | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05965479 | Apr 2024 → Mar 2026 overdue | gastroesophageal adenocarcinoma | University of Southampton | Recruiting | No outcome recorded |
| Phase 2 | NCT06253650 | Mar 2024 → Mar 2027 expected | gastric cancer | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT06271837 | Feb 2024 → Feb 2027 expected | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05704829 | Feb 2024 → Jun 2030 expected | HER2 positive breast carcinoma | West German Study Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06088056 | Nov 2023 → Jun 2024 overdue | breast cancer, metastatic malignant neoplasm in the brain | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05710666 | Oct 2023 → Sep 2025 overdue | HER2 positive breast carcinoma | Cancer Trials Ireland | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05900206 | Oct 2023 → Apr 2027 expected | breast cancer | Karolinska University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06837792 | Oct 2023 → Oct 2026 expected | Her2-receptor negative breast cancer | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT05744375 | Sep 2023 → Jul 2025 | breast cancer | Spanish Breast Cancer Research Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06058988 | Sep 2023 → Sep 2027 expected | brain cancer, glioblastoma, neoplastic meningitis | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05953168 | Aug 2023 → Aug 2024 overdue | triple-negative breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05480384 | Jul 2023 → May 2025 overdue | HER2 positive breast carcinoma, esophageal adenocarcinoma, gastroesophageal cancer | Brown University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05845450 | May 2023 → May 2027 expected | colorectal carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT05795101 | May 2023 → Dec 2027 expected | HER2 positive breast carcinoma, inflammatory breast carcinoma | Filipa Lynce, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05408845 | Mar 2023 → Jul 2028 expected | major salivary gland carcinoma | NRG Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT05246514 | Jul 2022 → Nov 2024 overdue | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05034887 | Jan 2022 → Mar 2028 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | National Cancer Center Hospital East | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04989816 | Aug 2021 → Jun 2023 | gastroesophageal adenocarcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT04644237 | Mar 2021 → Dec 2022 | non-small cell lung carcinoma | Daiichi Sankyo | Completed | Met primary |
| Phase 2 | NCT04616560 | Mar 2021 → Dec 2027 expected | desmoplastic small round cell tumor, kidney Wilms tumor, osteosarcoma | National Cancer Institute (NCI) | Recruiting | Missed primary |
| Phase 2 | NCT04744831 | Mar 2021 → Nov 2022 | colorectal cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT04639219 | Dec 2020 → Jan 2023 overdue | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04539938 | Dec 2020 → Jul 2024 | HER2 positive breast carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT04553770 | Oct 2020 → Dec 2026 expected | female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04482309 | Aug 2020 → Mar 2027 expected | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04752059 | Jul 2020 → May 2023 | breast cancer | Medical University of Vienna | Completed | Met primary |
| Phase 2 | NCT04379596 | Jun 2020 → Jun 2027 expected | gastric cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT04420598 | May 2020 → Sep 2021 | HER2 positive breast carcinoma, malignant leptomeningeal tumor, metastatic malignant neoplasm in the brain | MedSIR | Completed | Met primary |
| Phase 2 | NCT04014075 | Nov 2019 → Nov 2021 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT04132960 | Oct 2019 → Oct 2021 | breast neoplasm | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT03505710 | May 2018 → May 2021 | non-small cell lung carcinoma | Daiichi Sankyo | Terminated | No outcome recorded |
| Phase 2 | NCT03384940 | Feb 2018 → Aug 2019 | colorectal neoplasm | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT03334617 | Dec 2017 → Sep 2024 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03329690 | Nov 2017 → Nov 2019 | digestive system neoplasm | Daiichi Sankyo | Completed | Met primary |
| Phase 2 | NCT03248492 | Aug 2017 → Mar 2019 | breast cancer | Daiichi Sankyo | Terminated | No outcome recorded |
| Phase 2 | NCT02693535 | Mar 2016 → Dec 2027 expected | non-Hodgkin lymphoma, plasma cell myeloma | American Society of Clinical Oncology | Recruiting | Mixed |
| Phase 321 trials · 8 met primary | ||||||
| Phase 3 | NCT07683754 | Sep 2026 → Jul 2030 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Daiichi Sankyo | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06585969 | 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 | NCT06899126 | Oct 2025 → Apr 2030 expected | non-small cell lung carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT07022483 | Sep 2025 → Mar 2032 expected | endometrial cancer | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT06643585 | Apr 2025 → Apr 2032 expected | breast cancer | University of Ulm | Recruiting | No outcome recorded |
| Phase 3 | NCT06989112 | Mar 2025 → Jan 2029 expected | endometrial cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06819007 | Mar 2025 → Nov 2028 expected | ovarian cancer | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT06764875 | Mar 2025 → Apr 2029 expected | gastroesophageal junction adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06731478 | Feb 2025 → Jun 2028 expected | gastric cancer, gastroesophageal junction adenocarcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT06467357 | Aug 2024 → Jun 2028 expected | biliary tract cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT05950945 | Dec 2023 → Oct 2027 expected | breast cancer | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT05048797 | Oct 2021 → Jun 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT05113251 | Oct 2021 → Mar 2025 overdue | HER2 positive breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04739761 | Jun 2021 → Feb 2024 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04704934 | May 2021 → Aug 2026 overdue | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Daiichi Sankyo | Active not recruiting | Met primary |
| Phase 3 | NCT04784715 | Apr 2021 → Jul 2026 overdue | HER2 positive breast carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT04622319 | Dec 2020 → Jul 2025 overdue | HER2 positive breast carcinoma, invasive breast carcinoma | Daiichi Sankyo | Active not recruiting | Met primary |
| Phase 3 | NCT04494425 | Jul 2020 → Mar 2024 overdue | breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03734029 | Dec 2018 → Jan 2022 | breast cancer | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT03529110 | Aug 2018 → May 2021 | breast cancer | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT03523585 | Aug 2018 → Jun 2022 | breast cancer | Daiichi Sankyo | Completed | Met primary |
| Phase 45 trials | ||||||
| Phase 4 | NCT07162259 | Oct 2025 → Dec 2027 expected | breast cancer | Yan Xue | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06429761 | Jan 2025 → Oct 2026 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06245824 | Jan 2024 → Mar 2026 overdue | breast cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06230055 | Jan 2024 → Jan 2026 overdue | Her2-receptor negative breast cancer, malignant leptomeningeal tumor | Fudan University | Recruiting | No outcome recorded |
| Phase 4 | NCT05376878 | Dec 2022 → Apr 2027 expected | invasive breast carcinoma, metastatic malignant neoplasm in the brain | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07281001 | Dec 2025 → May 2026 overdue | HER2 positive breast carcinoma | Blokhin's Russian Cancer Research Center | Recruiting | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07086768 Background | Jan 2026 → Aug 2027 expected | metastatic malignant neoplasm | Lei Zheng | Recruiting | No outcome recorded |
| Phase 1 | NCT06840886 Background | Mar 2025 → Apr 2029 expected | breast cancer, central nervous system neoplasm, cholangiocarcinoma, endometrial cancer +3 | Pheast Therapeutics | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07157956 Background | Sep 2025 → Aug 2028 expected | neoplasm | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06771622 Background | Mar 2025 → Jan 2028 expected | — | FBD Biologics Limited | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06324357 Background | Jun 2024 → Jan 2029 expected | breast cancer, colorectal cancer, esophageal adenocarcinoma, gastric adenocarcinoma +1 | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 2 | NCT07474558 Background | Sep 2026 → Jan 2030 expected | alopecia, metastatic neoplasm | Jules Bordet Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07678957 Comparator | Aug 2026 → Dec 2028 expected | breast cancer | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07630103 Comparator | Jun 2026 → Jun 2031 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07416253 Comparator | Mar 2026 → Mar 2027 expected | breast cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07394218 Background | Dec 2025 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06102824 Comparator | Oct 2024 → Jun 2027 expected | Her2-receptor negative breast cancer | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04986579 Background | Oct 2021 → Jun 2028 expected | breast cancer, chemotherapy-induced alopecia | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT07578116 Background | Mar 2027 → May 2032 expected | HER2 positive breast carcinoma, female breast carcinoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07828054 Background | Dec 2026 → Dec 2030 expected | breast cancer, interstitial lung disease | Mario Negri Institute for Pharmacological Research | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07543536 Background | May 2026 → Apr 2029 expected | breast cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07060807 Comparator | Jul 2025 → Jul 2033 expected | breast neoplasm | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07371910 Comparator | Jun 2024 → Mar 2031 expected | Her2-receptor negative breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 123
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Alexion Pharmaceuticals, Inc. | Regulatory Enhertu recommended for approval in the EU by CHMP as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment. |
| 2026-09-14 | Alexion Pharmaceuticals, Inc. | Results Enhertu demonstrated a median progression-free survival of 14.3 months as 1st-line therapy in patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial astrazeneca.com ↗
Median PFS was 14.3 months with Enhertu compared to 8.3 months for pembrolizumab plus chemotherapy as assessed by blinded independent central review (BICR). |
| 2026-09-01 | Alexion Pharmaceuticals, Inc. | Regulatory Enhertu plus pertuzumab approved in the EU as first new regimen in more than a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. |
| 2026-08-17 | Alexion Pharmaceuticals, Inc. | Results Enhertu demonstrated statistically significant and clinically meaningful improvement in progression-free survival as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial astrazeneca.com ↗ |
| 2026-07-24 | AstraZeneca | Regulatory Enhertu plus pertuzumab recommended for approval in the EU by CHMP as 1st-line treatment for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. |
| 2026-06-29 | AstraZeneca | Regulatory Enhertu approved in the EU as first tumour agnostic HER2-directed therapy and antibody drug conjugate for patients with previously treated HER2-positive metastatic solid tumours astrazeneca.com ↗ |
| 2026-05-22 | AstraZeneca | Regulatory Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours astrazeneca.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from a subgroup of patients with HER2-positive (IHC 3+) tumours across three Phase II trials, DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 , in which Enhertu demonstrated clinically meaningful responses across a broad range of tumours. |
| 2026-05-21 | Boehringer Ingelheim | Results Boehringer Ingelheim's oncology portfolio shows strong promise across multiple cancers at ASCO 2026 prnewswire.com ↗
Encouraging clinical activity was observed in heavily pretreated patients with HER2-positive mBC treated with HERNEXEOS in combination with trastuzumab emtansine (Cohort A) and trastuzumab deruxtecan (Cohort B). |
| 2026-05-15 | AstraZeneca | Regulatory Enhertu approved in the US for two new indications for patients with HER2-positive early breast cancer astrazeneca.com ↗
In the adjuvant setting, Enhertu has been approved for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment. |
| 2026-03-09 | AstraZeneca | Regulatory Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US |
| 2025-12-22 | AstraZeneca | Regulatory Enhertu granted Breakthrough Therapy Designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer astrazeneca.com ↗ |
| 2025-12-15 | AstraZeneca | Regulatory Enhertu plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. |
| 2025-10-18 | AstraZeneca | Results Enhertu reduced the risk of disease recurrence or death by 53% vs. T-DM1 in patients with high-risk HER2-positive early breast cancer following neoadjuvant therapy in DESTINY-Breast05 Phase III trial astrazeneca.com ↗
Results showed Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1 as a post-neoadjuvant treatment (based on an IDFS hazard ratio [HR] of 0.47, 95% confidence interval [CI] 0.34-0.66, p<0.0001). |
| 2025-10-18 | AstraZeneca | Results Enhertu followed by THP before surgery resulted in a pathologic complete response in 67% of patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial astrazeneca.com ↗
Positive results from the DESTINY-Breast11 Phase III trial showed Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate. |
| 2025-09-29 | AstraZeneca | Results Enhertu demonstrated highly statistically significant and clinically meaningful improvement in invasive disease-free survival vs. T-DM1 in DESTINY-Breast05 Phase III trial in patients with high-risk early breast cancer following neoadjuvant therapy astrazeneca.com ↗ |
| 2025-09-24 | AstraZeneca | Regulatory Enhertu plus pertuzumab granted Priority Review in the US as 1st-line treatment for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been accepted and granted Priority Review in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. |
| 2025-09-08 | Daiichi Sankyo | Regulatory Anvisa aprova nova indicação para tratamento de câncer de mama com expressão ultrabaixa de HER2 daiichisankyo.com.br ↗
A Agência Nacional de Vigilância Sanitária (Anvisa) aprovou uma nova indicação do medicamento trastuzumabe deruxtecana, criado pela Daiichi Sankyo e sendo desenvolvido e comercializado em conjunto pela Daiichi Sankyo e pela AstraZeneca. |
| 2025-06-02 | AstraZeneca | Results Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial astrazeneca.com ↗
In a prespecified interim analysis, Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP (based on a hazard ratio [HR] of 0.56; 95% confidence interval [CI] 0.44-0.71; p<0.00001). |
| 2025-05-07 | AstraZeneca | Results Enhertu followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial astrazeneca.com ↗ |
| 2025-05-01 | InxMed (Shanghai) Co., Ltd. | Results 应世生物于AACR 2025年会公布Ifebemtinib增效RAS抑制剂及缓解ADC相关毒性的研究成果 inxmed.com ↗
本研究发现，FAK抑制剂Ifebemtinib可有效缓解Enhertu诱导的ILD。 |
| 2025-04-21 | AstraZeneca | Results Enhertu plus pertuzumab demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival vs. THP as 1st-line therapy for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
The PFS improvement was seen across all pre-specified patient subgroups with Enhertu in combination with pertuzumab. |
| 2025-04-04 | AstraZeneca | Regulatory Enhertu approved in the EU as first HER2-directed therapy for patients with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer following at least one endocrine therapy astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. |
| 2025-02-28 | AstraZeneca | Regulatory Enhertu recommended for approval in the EU by CHMP for patients with HER2-low or HER2-ultralow metastatic breast cancer following at least one endocrine therapy astrazeneca.com ↗ |
| 2025-01-27 | AstraZeneca | Regulatory Enhertu approved in the US as first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies astrazeneca.com ↗ |
| 2024-10-14 | AstraZeneca | Regulatory Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic non-small cell lung cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 ( ERBB2 ) mutations and who have received a prior systemic therapy. |
| 2024-10-01 | AstraZeneca | Regulatory Enhertu granted Priority Review in the US for patients with HER2-low or HER2-ultralow metastatic breast cancer who have received at least one line of endocrine therapy astrazeneca.com ↗ |
| 2024-09-13 | AstraZeneca | Results Enhertu showed substantial clinical activity in patients with HER2-positive metastatic breast cancer and brain metastases astrazeneca.com ↗
In patients with brain metastases at baseline, the primary endpoint of progression-free survival (PFS) by independent central review showed a 12-month PFS rate of 61.6%. |
| 2024-08-13 | AstraZeneca | Regulatory Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received two or more prior treatment regimens. |
| 2024-06-02 | AstraZeneca | Results Enhertu demonstrated a median progression-free survival of 13.2 months in HR-positive, HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy astrazeneca.com ↗
Median PFS was 13.2 months in the Enhertu arm compared to 8.1 months for chemotherapy. |
| 2024-05-22 | AstraZeneca | Results AstraZeneca furthers ambition to transform outcomes in early lung cancer and redefine metastatic breast cancer treatment at ASCO 2024 astrazeneca.com ↗
A clinically meaningful PFS improvement was also seen in patients with HER2-ultralow expression. |
| 2024-04-29 | AstraZeneca | Results Enhertu demonstrated statistically significant and clinically meaningful improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy in DESTINY-Breast06 Phase III trial astrazeneca.com ↗
A statistically significant and clinically meaningful improvement in PFS was also observed in the overall trial population (patients with HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining; IHC >0<1+] metastatic breast cancer). |
| 2024-04-06 | AstraZeneca | Regulatory Enhertu approved in the US as first tumour-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumours astrazeneca.com ↗
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). |
| 2024-01-29 | AstraZeneca | Regulatory Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours astrazeneca.com ↗ |
| 2023-11-29 | Inmune Bio, Inc. | Results INmune Bio Inc. Demonstrates that INB03 Enhances the Uptake of Trastuzumab Deruxtecan in HER2+ Breast Cancer with MUC4 Expression in Poster Presented at San Antonio Breast Cancer Symposium inmunebio.com ↗
The poster, titled, “ Blocking soluble TNF to improve potency of trastuzumab-deruxtecan by increasing internalization and antitumor innate immune response in a resistant HER2-positive breast cancer model, ” shows that INB03 improves the potency of T-DXd in a model of immunotherapy resistant HER2+ breast cancer. |
| 2023-10-23 | AstraZeneca | Results Enhertu demonstrated clinically meaningful survival across multiple HER2-expressing advanced solid tumours in DESTINY-PanTumor02 Phase II trial astrazeneca.com ↗
Positive results from the primary analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that Enhertu (trastuzumab deruxtecan) continued to demonstrate clinically meaningful and durable responses, leading to a clinically meaningful survival benefit in previously treated patients across multiple HER2-expressing advanced solid tumours. |
| 2023-10-23 | AstraZeneca | Regulatory Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer astrazeneca.com ↗ |
| 2023-09-15 | AstraZeneca | Regulatory Enhertu recommended for approval in the EU by CHMP for patients with HER2-mutant advanced non-small cell lung cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. |
| 2023-09-11 | AstraZeneca | Results Enhertu demonstrated strong and durable tumour responses in previously treated HER2-mutant advanced lung cancer in DESTINY-Lung02 Phase II trial astrazeneca.com ↗
Results from the primary analysis of the DESTINY-Lung02 Phase II trial showed Enhertu (trastuzumab deruxtecan) continued to demonstrate strong and durable tumour responses in previously treated patients with HER2-mutant (HER2m) unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC). |
| 2023-07-27 | AstraZeneca | Results Enhertu demonstrated clinically meaningful progression-free survival and overall survival across multiple HER2-expressing advanced solid tumours in DESTINY-PanTumor02 Phase II trial astrazeneca.com ↗ |
| 2023-07-12 | AstraZeneca | Regulatory Enhertu approved in China as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer astrazeneca.com ↗ |
| 2023-06-05 | AstraZeneca | Results Enhertu demonstrated clinically meaningful and durable responses in patients across multiple HER2-expressing advanced solid tumours astrazeneca.com ↗
Positive results from an interim analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that Enhertu (trastuzumab deruxtecan) demonstrated clinically meaningful and durable responses across a broad range of HER2-expressing advanced solid tumours in previously treated patients. |
| 2023-03-06 | AstraZeneca | Results Enhertu showed clinically meaningful and durable responses across multiple HER2-expressing tumour types in DESTINY-PanTumor02 Phase II trial astrazeneca.com ↗ |
| 2023-02-24 | AstraZeneca | Regulatory Enhertu approved in China for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens astrazeneca.com ↗
Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. |
| 2023-01-26 | AstraZeneca | Regulatory Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. |
| 2022-12-19 | AstraZeneca | Regulatory Enhertu recommended for approval in the EU by CHMP for patients with HER2-low metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. |
| 2022-12-19 | AstraZeneca | Regulatory Enhertu approved in the EU for patients with previously treated HER2-positive advanced gastric cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. |
| 2022-12-07 | AstraZeneca | Results Enhertu achieved statistically significant overall survival, reducing the risk of death by 36% vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer in DESTINY-Breast03 astrazeneca.com ↗
In the key secondary endpoint analysis of OS for DESTINY-Breast03, Enhertu demonstrated a 36% reduction in risk of death versus T-DM1 (based on a hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.47-0.87; p=0.0037). |
| 2022-11-14 | AstraZeneca | Regulatory Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive advanced gastric cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. |
| 2022-09-11 | AstraZeneca | Results Enhertu continues to demonstrate clinically meaningful tumour response in patients with HER2-mutant metastatic non-small cell lung cancer astrazeneca.com ↗
Detailed positive results from an interim analysis of the DESTINY-Lung02 Phase II trial showed Enhertu (trastuzumab deruxtecan) demonstrated clinically meaningful tumour responses in previously-treated patients with HER2-mutant (HER2m) unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC). |
| 2022-08-15 | AstraZeneca | Results Enhertu significantly delayed disease progression in DESTINY-Breast02 Phase III trial vs. physician’s choice of treatment in patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
The trial also met the key secondary endpoint of improved overall survival (OS). |
| 2022-08-12 | AstraZeneca | Regulatory Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a Food and Drug Administration (FDA)-approved test, and who have received a prior systemic therapy. |
| 2022-08-06 | AstraZeneca | Regulatory Enhertu approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer astrazeneca.com ↗ |
| 2022-07-25 | AstraZeneca | Regulatory Enhertu granted Priority Review in the US for patients with HER2-low metastatic breast cancer astrazeneca.com ↗
The application has been granted Priority Review. |
| 2022-07-19 | AstraZeneca | Regulatory Enhertu approved in the EU for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. |
| 2022-06-27 | AstraZeneca | Regulatory Enhertu recommended for approval in the EU by CHMP for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. |
| 2022-06-05 | AstraZeneca | Results Enhertu reduced the risk of disease progression or death by 50% vs. chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive and HR-negative disease astrazeneca.com ↗
Enhertu met the primary endpoint of progression-free survival in patients with HR-positive disease, reducing the risk of disease progression or death by 49% vs. chemotherapy |
| 2022-05-23 | AstraZeneca | Results AstraZeneca aims to transform cancer care with practice-changing data at ASCO 2022 astrazeneca.com ↗
Enhertu data will show the potential to improve survival for metastatic breast cancer patients and define a new segment of HER2-low disease |
| 2022-05-05 | AstraZeneca | Regulatory Enhertu approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen astrazeneca.com ↗ |
| 2022-04-27 | AstraZeneca | Regulatory Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. |
| 2022-04-19 | AstraZeneca | Regulatory Enhertu granted Priority Review in the US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer astrazeneca.com ↗
The application has also been granted Priority Review. |
| 2022-03-28 | AstraZeneca | Results AstraZeneca aims to transform the oncology treatment landscape with diverse early pipeline and novel combinations at AACR astrazeneca.com ↗
Preclinical data will be presented that support this hypothesis showing the activity of Enhertu (trastuzumab deruxtecan) in combination with DDR agents including PARP1-selective inhibitors. |
| 2022-02-21 | AstraZeneca | Results Enhertu significantly improved both progression-free and overall survival in DESTINY-Breast04 trial in patients with HER2-low metastatic breast cancer astrazeneca.com ↗ |
| 2022-01-17 | AstraZeneca | Regulatory Enhertu granted Priority Review in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen astrazeneca.com ↗
The application has also been granted Priority Review. |
| 2021-12-09 | AstraZeneca | Results Enhertu additional analyses further reinforce ground-breaking efficacy in patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
Additionally, in this subgroup, Enhertu improved PFS to a median of 15 months versus 3 months for T-DM1. |
| 2021-10-04 | AstraZeneca | Regulatory Enhertu granted Breakthrough Therapy Designation in US for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens astrazeneca.com ↗
The Food and Drug Administration (FDA) has granted Enhertu (trastuzumab deruxtecan), Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. |
| 2021-09-18 | AstraZeneca | Results Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
At a prespecified interim analysis of DESTINY-Breast03, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 (hazard ratio [HR] 0.28; 95% confidence interval [CI] 0.22-0.37; p=7.8x10 -22 ). |
| 2021-09-18 | AstraZeneca | Results Enhertu demonstrated robust and durable tumour response of 54.9% in patients with HER2-mutant metastatic non-small cell lung cancer astrazeneca.com ↗
Primary results from the HER2m cohort (cohort 2) of DESTINY-Lung01 in previously treated HER2m NSCLC demonstrated a confirmed objective response rate (ORR) of 54.9% in patients treated with Enhertu (6.4 mg/kg) as assessed by independent central review (ICR). |
| 2021-09-17 | AstraZeneca | Results Enhertu demonstrated clinically meaningful and durable response in patients with HER2-positive advanced gastric cancer in DESTINY-Gastric02 Phase II trial astrazeneca.com ↗
Detailed results from the positive Phase II DESTINY-Gastric02 trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), provided a clinically meaningful and durable tumour response in patients with HER2-positive metastatic and/or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with a trastuzumab-containing regimen. |
| 2021-09-02 | AstraZeneca | Results AstraZeneca lung and breast cancer data at WCLC and ESMO 2021 underscore ambition to revolutionise outcomes for patients astrazeneca.com ↗
In August 2021 , the Independent Data Monitoring Committee recommended unblinding the trial based on a planned interim analysis showing a highly statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus trastuzumab emtansine (T-DM1). |
| 2021-08-09 | AstraZeneca | Results Enhertu significantly improved progression-free survival in DESTINY-Breast03 head-to-head trial vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1). |
| 2021-01-29 | Daiichi Sankyo | Results Datopotamab Deruxtecan and ENHERTU® Show Promising Early Clinical Activity in Patients with Advanced Non-Small Cell Lung Cancer daiichisankyo.com ↗
Additionally, an interim analysis of the HER2 overexpressing cohort of the DESTINY-Lung01 phase 2 trial showed preliminary evidence of antitumor activity for ENHERTU, a HER2 directed ADC, in patients with metastatic NSCLC. |
| 2021-01-29 | AstraZeneca | Results Datopotamab deruxtecan and Enhertu show promising early clinical activity in patients with advanced non-small cell lung cancer astrazeneca.com ↗
Additionally, an interim analysis of the HER2-overexpressing cohort of the DESTINY-Lung01 Phase II trial showed preliminary evidence of antitumour activity for Enhertu , a HER2-directed ADC, in patients with metastatic NSCLC. |
| 2021-01-20 | Daiichi Sankyo | Regulatory ENHERTU® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗
ENHERTU® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer |
| 2021-01-20 | AstraZeneca | Regulatory Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer astrazeneca.com ↗ |
| 2021-01-18 | Daiichi Sankyo | Regulatory ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer daiichisankyo.com ↗
ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer |
| 2021-01-18 | AstraZeneca | Regulatory Enhertu approved in the US for the treatment of patients with previously treated HER2-positive advanced gastric cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. |
| 2020-12-14 | Daiichi Sankyo | Regulatory Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2020-12-14 | AstraZeneca | Regulatory Trastuzumab deruxtecan recommended for approval in the EU by CHMP for HER2-positive metastatic breast cancer astrazeneca.com ↗ |
| 2020-12-10 | Daiichi Sankyo | Results Results from First Combination Trial of ENHERTU® and Immune Checkpoint Inhibitor in Patients with HER2 Expressing Metastatic Breast Cancer Presented at the 2020 San Antonio Breast Cancer Symposium daiichisankyo.com ↗
Results were presented in a Spotlight Poster Discussion at the virtual 2020 San Antonio Breast Cancer Symposium (#SABCS20). |
| 2020-12-10 | Daiichi Sankyo | Results ENHERTU® Continues to Demonstrate Durable Responses with New Data from DESTINY-Breast01 in HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗
With a median duration of response greater than twenty months, the updated results of DESTINY-Breast01 are unprecedented. |
| 2020-12-10 | AstraZeneca | Results Enhertu continues to demonstrate durable responses with new data from DESTINY-Breast01 in HER2-positive metastatic breast cancer astrazeneca.com ↗
With a median duration of follow-up of 20.5 months, patients treated with Enhertu (5.4 mg/kg) achieved an objective response rate (ORR) of 61.4% and a median duration of response (DoR) of 20.8 months. |
| 2020-12-03 | AstraZeneca | Results AstraZeneca demonstrates growing leadership in breast cancer at SABCS with data from its innovative medicines and robust pipeline astrazeneca.com ↗
New data from the DESTINY-Breast01 Phase II trial reinforce the efficacy of Enhertu in HER2-positive metastatic breast cancer |
| 2020-10-28 | Daiichi Sankyo | Regulatory ENHERTU® Granted Priority Review in the U.S. for Treatment of HER2 Positive Metastatic Gastric Cancer daiichisankyo.com ↗
ENHERTU® Granted Priority Review in the U.S. for Treatment of HER2 Positive Metastatic Gastric Cancer |
| 2020-10-28 | AstraZeneca | Regulatory Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer astrazeneca.com ↗ |
| 2020-09-25 | Daiichi Sankyo | Regulatory ENHERTU® Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer daiichisankyo.com ↗
ENHERTU® Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer |
| 2020-07-07 | Daiichi Sankyo | Regulatory EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗
Trastuzumab deruxtecan was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP). |
| 2020-06-01 | Daiichi Sankyo | Results ENHERTU® Significantly Improved Tumor Response Rate and Overall Survival in HER2 Positive Metastatic Gastric Cancer in Pivotal Phase 2 DESTINY-Gastric01 Trial daiichisankyo.com ↗
ENHERTU® Significantly Improved Tumor Response Rate and Overall Survival in HER2 Positive Metastatic Gastric Cancer in Pivotal Phase 2 DESTINY-Gastric01 Trial |
| 2020-06-01 | Daiichi Sankyo | Results ENHERTU® Achieved a Tumor Response Rate of 45.3% in Patients with HER2 Positive Metastatic Colorectal Cancer in Phase 2 DESTINY-CRC01 Trial daiichisankyo.com ↗
A disease control rate (DCR) of 83.0% was observed with a median progression-free survival (PFS) of 6.9 months. |
| 2020-06-01 | Daiichi Sankyo | Results ENHERTU® Demonstrated Meaningful Clinical Activity in Patients with HER2 Mutant Non-Small Cell Lung Cancer in Interim Analysis of Phase 2 DESTINY-Lung01 Trial daiichisankyo.com ↗
61.9% of patients with HER2 mutant metastatic non-small cell lung cancer treated with ENHERTU achieved a tumor response |
| 2020-05-29 | AstraZeneca | Results Enhertu significantly improved tumour response rate and overall survival in HER2-positive metastatic gastric cancer in Phase II DESTINY-Gastric01 trial astrazeneca.com ↗
Patients treated with Enhertu had a 41% reduction in the risk of death versus patients treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; p=0.0097) at a pre-specified interim analysis. |
| 2020-05-29 | AstraZeneca | Results Enhertu demonstrated meaningful clinical activity in patients with HER2-mutant non-small cell lung cancer in interim analysis of Phase II DESTINY-Lung01 trial astrazeneca.com ↗
The primary endpoint of confirmed objective response rate (ORR), assessed by independent central review, was 61.9% for patients treated with Enhertu monotherapy (6.4mg/kg). |
| 2020-05-29 | AstraZeneca | Results Enhertu achieved a tumour response rate of 45.3% in patients with HER2-positive metastatic colorectal cancer in Phase II DESTINY-CRC01 trial astrazeneca.com ↗
The primary endpoint of confirmed objective response rate (ORR), assessed by independent central review, showed 45.3% of patients with HER2-positive (defined as IHC3+ or IHC2+/ISH+) advanced colorectal cancer treated with Enhertu monotherapy (6.4mg/kg) achieved a tumour response. |
| 2020-05-22 | Daiichi Sankyo | Regulatory ENHERTU® Granted Orphan Drug Designation in the U.S. for Gastric Cancer daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Orphan Drug Designation (ODD) in the U.S. for the treatment of patients with gastric cancer, including gastroesophageal junction cancer. |
| 2020-05-22 | AstraZeneca | Regulatory Enhertu granted Orphan Drug Designation in the US for gastric cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer. |
| 2020-05-18 | Daiichi Sankyo | Regulatory ENHERTU® Granted Breakthrough Therapy Designation in the U.S. for HER2 Mutant Metastatic Non-Small Cell Lung Cancer daiichisankyo.com ↗
ENHERTU® Granted Breakthrough Therapy Designation in the U.S. for HER2 Mutant Metastatic Non-Small Cell Lung Cancer |
| 2020-05-18 | AstraZeneca | Regulatory Enhertu granted Breakthrough Therapy Designation in the US for HER2-mutant metastatic non-small cell lung cancer astrazeneca.com ↗ |
| 2020-05-11 | Daiichi Sankyo | Regulatory ENHERTU® Granted Breakthrough Therapy Designation in the U.S. for HER2 Positive Metastatic Gastric Cancer daiichisankyo.com ↗
ENHERTU® Granted Breakthrough Therapy Designation in the U.S. for HER2 Positive Metastatic Gastric Cancer |
| 2020-05-11 | AstraZeneca | Regulatory Enhertu granted Breakthrough Therapy Designation in the US for HER2-positive metastatic gastric cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab. |
| 2020-05-07 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in Japan for Treatment of Patients with HER2 Positive Metastatic Gastric Cancer daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan (DS-8201), a HER2 directed antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic gastric cancer. |
| 2020-03-25 | Daiichi Sankyo | Regulatory ENHERTU® Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer daiichisankyo.com ↗
ENHERTU® Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer |
| 2020-01-27 | Daiichi Sankyo | Results Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint daiichisankyo.com ↗
The trial met its primary endpoint, achieving a statistically significant and clinically meaningful improvement in objective response rate (ORR), as assessed by an independent review committee, in patients treated with DS-8201 versus investigator’s choice of chemotherapy (irinotecan or paclitaxel monotherapy). |
| 2020-01-27 | AstraZeneca | Results Phase II DESTINY-Gastric01 trial of Enhertu versus chemotherapy met primary endpoint astrazeneca.com ↗
The trial met its primary endpoint of an improvement in ORR, as assessed by an independent review committee, in patients treated with Enhertu compared to investigator’s choice of chemotherapy (irinotecan or paclitaxel monotherapy). |
| 2019-12-23 | Daiichi Sankyo | Regulatory ENHERTU® Approved in the U.S. for HER2 Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens daiichisankyo.com ↗
This indication is approved under accelerated approval based on tumor response rate and duration of response. |
| 2019-12-23 | AstraZeneca | Regulatory Enhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. |
| 2019-12-12 | Daiichi Sankyo | Results DS-8201 ([Fam-] Trastuzumab Deruxtecan) Achieved A Tumor Response Rate of 60.9% in Pivotal Phase 2 HER2 Positive Metastatic Breast Cancer Trial daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today presented positive detailed data from the global pivotal phase 2 single-arm DESTINY-Breast01 trial of DS-8201 ([fam]-trastuzumab deruxtecan), an investigational HER2 targeting antibody drug conjugate (ADC), in patients with HER2 positive metastatic breast cancer. |
| 2019-12-11 | AstraZeneca | Results Trastuzumab deruxtecan achieved a tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial astrazeneca.com ↗
The primary endpoint of objective response rate (ORR), confirmed by independent central review, was 60.9% with trastuzumab deruxtecan monotherapy (5.4mg/kg). |
| 2019-10-17 | Daiichi Sankyo | Regulatory [Fam-] Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. |
| 2019-10-17 | AstraZeneca | Regulatory Trastuzumab deruxtecan granted FDA Priority Review for treatment of patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. |
| 2019-09-09 | Daiichi Sankyo | Regulatory Daiichi Sankyo Advances [Fam-] Trastuzumab Deruxtecan (DS-8201) in Japan with Regulatory Submission in HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗
Daiichi Sankyo Advances [Fam-] Trastuzumab Deruxtecan (DS-8201) in Japan with Regulatory Submission in HER2 Positive Metastatic Breast Cancer |
| 2019-05-08 | Daiichi Sankyo | Results Daiichi Sankyo Announces [Fam-] Trastuzumab Deruxtecan Demonstrated Clinically Meaningful Response in Patients with Refractory HER2 Positive Metastatic Breast Cancer, a Population with High Unmet Need daiichisankyo.com ↗ |
| 2019-05-08 | AstraZeneca | Results Trastuzumab deruxtecan demonstrated clinically-meaningful response in patients with refractory HER2-positive metastatic breast cancer, a population with high unmet need astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced positive top-line results for the pivotal Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201). |
| 2018-12-10 | Daiichi Sankyo | Results Daiichi Sankyo Presents Updated Phase 1 Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Low Expressing Metastatic Breast Cancer at 2018 San Antonio Breast Cancer Symposium (SABCS) daiichisankyo.com ↗
A further subgroup analysis of 38 patients whose disease was also hormone receptor (HR) positive showed a 47.4 percent confirmed overall response rate and 81.6 percent disease control rate |
| 2018-10-22 | Daiichi Sankyo | Results Daiichi Sankyo Presents Updated Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Expressing Advanced Colorectal Cancer at 2018 European Society for Medical Oncology (ESMO) Congress daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that updated phase 1 safety and efficacy data for [fam-] trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate (ADC), were presented for a subgroup of patients with heavily pretreated HER2 expressing colorectal cancer at the 2018 European Society for Medical Oncology (ESMO) Congress in Munich, Germany. |
| 2018-09-25 | Daiichi Sankyo | Results Daiichi Sankyo Presents Updated Results for [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Mutated or HER2 Expressing Non-Small Cell Lung Cancer at IASLC 19th World Conference on Lung Cancer daiichisankyo.com ↗
Updated subgroup analysis from ongoing phase 1 study of [fam-] trastuzumab deruxtecan (DS-8201) demonstrated a confirmed overall response rate of 72.7 percent and a disease control rate of 100 percent in 11 patients with heavily pretreated HER2 mutated non-small cell lung cancer (NSCLC) |
| 2018-06-01 | Daiichi Sankyo | Results Daiichi Sankyo Presents Long-Term Phase 1 Results of Antibody Drug Conjugate DS-8201 in Patients with HER2-Expressing Breast, Gastric and Other Solid Cancers at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting daiichisankyo.com ↗
Updated subgroup analysis in 34 heavily pretreated patients with HER2-low-expressing metastatic breast cancer demonstrated a 50.0 percent confirmed overall response rate and an 85.3 percent disease control rate with DS-8201 |
| 2018-03-27 | Daiichi Sankyo | Regulatory Daiichi Sankyo’s HER2-Targeting Antibody Drug Conjugate DS-8201 Receives SAKIGAKE Designation for Gastric Cancer from Japan MHLW daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), has received SAKIGAKE Designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW). |
| 2018-01-19 | Daiichi Sankyo | Results Daiichi Sankyo Presents Updated Data for DS-8201 in Patients with HER2-Expressing Gastric Cancer at ASCO 2018 Gastrointestinal Cancers Symposium daiichisankyo.com ↗
Updated analysis from ongoing phase 1 study of DS-8201 demonstrated a confirmed overall response rate of 45.5 percent and a disease control rate of 81.8 percent in 44 evaluable patients with HER2-expressing gastric cancer previously treated with trastuzumab and chemotherapy |
| 2017-12-08 | Daiichi Sankyo | Results Daiichi Sankyo Presents Updated Data for DS-8201 in Patients with HER2-Expressing Breast Cancer at San Antonio Breast Cancer Symposium daiichisankyo.com ↗
Updated preliminary results in a subgroup analysis of 57 efficacy evaluable patients with HER2-positive metastatic breast cancer pre-treated with ado-trastuzumab emtansine (T-DM1) showed that DS-8201 demonstrated a confirmed overall response rate of 61.4 percent (35 of 57 patients) and a disease control rate of 94.7 percent (54 of 57 patients). |
| 2017-09-12 | Daiichi Sankyo | Results Daiichi Sankyo Presents New Data for DS-8201 in Multiple HER2-Expressing Solid Tumors at European Society for Medical Oncology (ESMO) 2017 Congress daiichisankyo.com ↗
Preliminary results from subgroup analysis of ongoing phase 1 study demonstrate a 32 percent overall response rate and 82 percent disease control rate with DS-8201 in HER2-expressing metastatic solid tumors such as colon cancer, non-small cell lung cancer and other tumor types |
| 2017-08-30 | Daiichi Sankyo | Regulatory FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s DS-8201 for HER2-Positive Metastatic Breast Cancer daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1). |
| 2017-06-06 | Daiichi Sankyo | Results New Precision Medicine Data on DS-8201 in HER2-Expressing Breast Cancer Revealed at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting daiichisankyo.com ↗
Preliminary results from phase 1 study demonstrate a 46.7 percent overall response rate and 100 percent disease control rate with smart chemotherapy DS-8201 in a subgroup analysis of HER2-expressing metastatic breast cancer pre-treated with T-DM1 and pertuzumab |
| 2016-12-02 | Daiichi Sankyo | Regulatory U.S. FDA Grants Fast Track Designation for HER2-Targeting Antibody Drug Conjugate DS-8201 for HER2-Positive Metastatic Breast Cancer daiichisankyo.com ↗
U.S. FDA Grants Fast Track Designation for HER2-Targeting Antibody Drug Conjugate DS-8201 for HER2-Positive Metastatic Breast Cancer |
| 2016-10-11 | Daiichi Sankyo | Results Daiichi Sankyo Presents Late-Breaking Phase 1 Data for Novel Investigational HER2-Targeting Antibody Drug Conjugate DS-8201a in T-DM1 Pre-Treated Breast Cancer at the ESMO 2016 Congress daiichisankyo.com ↗
In 12 evaluable HER2+ breast cancer patients previously treated with ado-tratuzumab emtansine (T-DM1), the objective response rate was 42 percent with a disease control rate of 92 percent. |
All press releases naming this drug 143 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 143 releases opens the full record — a long page | ||
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 178 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | trastuzumab deruxtecan | “The treatment of metastatic breast cancer (mBC) has evolved significantly in the past several years with the approval of new targeted agents. Trastuzumab deruxtecan (T-DXd), an...” PMID 35642907 ↗ Aug 2022146“Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan, T-DM1) for at least 2 years in any line...” NCT06450314 ↗ “The purpose of this study is find out whether the combination of trastuzumab deruxtecan (T-DXd) and cetuximab is an effective treatment for participants with metastatic and/or...” NCT07691489 ↗ “Participants will receive 6 cycles of a standard intravenous or oral chemotherapy regimen or an Antibody-Drug Conjugate (ADC), selected by the investigator from...” NCT07371910 ↗ “Trastuzumab deruxtecan (T-DXd) has recently received approval as an antibody-drug conjugate for treating patients with metastatic breast cancer (BC) who have HER-2 protein...” NCT07828054 ↗ “This multi-center observational retrospective study will collect real-world clinical data from eligible patients with unresectable or metastatic HER2+ breast cancer who have...” NCT07281001 ↗ “This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast...” NCT06088056 ↗ “BACKGROUND: Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable...” PMID 32469182 ↗ May 2020 “Trastuzumab deruxtecan (DS-8201a, T-DXd) is a novel HER2-targeted antibody-drug coupling (ADC) approved by the FDA and NMPA for the treatment of HER2-positive and HER2-low...” NCT06733233 ↗ “Trastuzumab deruxtecan (DS-8201a) is a novel HER2-targeted antibody-drug conjugate with a humanised anti-HER2 antibody, cleavable peptide-based linker, and potent topoisomerase...” PMID 31047803 ↗ Apr 2019 “Trastuzumab deruxtecan (T-DXd) is approved in patients with HER2-positive advanced gastric or gastroesophageal adenocarcinoma after failure of at least one prior...” PMID 40200187 ↗ Apr 2025 |
| Known as | DS-8201 | “Trastuzumab deruxtecan (T-DXd, DS-8201, Enhertu) is a novel antibody drug conjugate that is comprised of 3 components: a humanized anti-HER2 IgG1 monoclonal antibody with the...” NCT06250777 ↗9“BACKGROUND: Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable...” PMID 32469182 ↗ May 2020 “BACKGROUND: Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable...” PMID 31825192 ↗ Dec 2019 “The efficacy and safety of trastuzumab deruxtecan (formerly DS-8201), a HER2 antibody-drug conjugate, in patients with HER2-mutant NSCLC have not been investigated extensively.” PMID 34534430 ↗ Sep 2021 “Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial.” PMID 33961795 ↗ May 2021 “Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several HER2-expressing solid tumors in multiple studies.” PMID 38231777 ↗ Apr 2024 “For patients failing first-line therapy, trastuzumab deruxtecan (T-DXd, DS-8201) has become the globally accepted second-line standard.” NCT07836257 ↗ “DS8201(5.4mg/kg, d1, q3w, ivgtt)” NCT06230055 ↗ |
| Known as | DS-8201a | “This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast...” NCT06088056 ↗14“Trastuzumab deruxtecan (DS-8201a, T-DXd) is a novel HER2-targeted antibody-drug coupling (ADC) approved by the FDA and NMPA for the treatment of HER2-positive and HER2-low...” NCT06733233 ↗ “Trastuzumab deruxtecan (DS-8201a) is a novel HER2-targeted antibody-drug conjugate with a humanised anti-HER2 antibody, cleavable peptide-based linker, and potent topoisomerase...” PMID 31047803 ↗ Apr 2019 “A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors...” NCT04482309 ↗ “Trastuzumab deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC)” NCT04042701 ↗ “Trastuzumab deruxtecan (T-DXd, DS-8201a)” NCT06486883 ↗ |
| Known as | DS-8201a (T-DXd) | “DS-8201a (T-DXd)” NCT04639219 ↗ |
| Known as | DS-8201a (trastuzumab derextecan) | “DS-8201a (trastuzumab derextecan)” NCT05950945 ↗ |
| Known as | DS-8210 | “multicenter single-arm phase II open label trial of Trastuzumab Deruxtecan (Enhertu, DS-8210).” NCT07126561 ↗ |
| Known as | ENHERTU | “Trastuzumab deruxtecan (T-DXd, DS-8201, Enhertu) is a novel antibody drug conjugate that is comprised of 3 components: a humanized anti-HER2 IgG1 monoclonal antibody with the...” NCT06250777 ↗3“The investigational study drug, fam-trastuzumab deruxtecan-nxki (ENHERTU® ), consists of an antibody component, MAAL-9001, covalently conjugated via a maleimide tetrapeptide...” NCT07691489 ↗ “multicenter single-arm phase II open label trial of Trastuzumab Deruxtecan (Enhertu, DS-8210).” NCT07126561 ↗ |
| Known as | fam-trastuzumab deruxtecan-nxki | “PURPOSE: The US Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd) for the treatment of adult patients with unresectable or metastatic...” PMID 36780610 ↗ Feb 20238“Trastuzumab deruxtecan (T-DXd, fam-trastuzumab deruxtecan-nxki) is a novel HER2- targeting antibody-drug conjugate (ADC).” NCT07428044 ↗ |
| Known as | SHR-A1811 | “Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer” NCT07393425 ↗ |
| Known as | T-DX | “Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases” NCT04752059 ↗ |
| Known as | T-DXd | “The treatment of metastatic breast cancer (mBC) has evolved significantly in the past several years with the approval of new targeted agents. Trastuzumab deruxtecan (T-DXd), an...” PMID 35642907 ↗ Aug 202259“Trastuzumab deruxtecan (T-DXd, DS-8201, Enhertu) is a novel antibody drug conjugate that is comprised of 3 components: a humanized anti-HER2 IgG1 monoclonal antibody with the...” NCT06250777 ↗ “This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate...” NCT07543536 ↗ “Trastuzumab deruxtecan (T-DXd) has recently received approval as an antibody-drug conjugate for treating patients with metastatic breast cancer (BC) who have HER-2 protein...” NCT07828054 ↗ “DESTINY-CRC01 (NCT03384940) was a multicentre, open-label, phase 2 study that investigated the safety and efficacy of trastuzumab deruxtecan (T-DXd) in patients with human...” PMID 39587050 ↗ Nov 2024 “This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer...” NCT06832202 ↗ “Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) consisting of the humanized anti-HER2 monoclonal antibody trastuzumab covalently linked to the topoisomerase...” NCT07825753 ↗ “This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast...” NCT06088056 ↗ “Trastuzumab deruxtecan (T-DXd) demonstrated strong and durable responses in patients with previously treated HER2 (ERBB2) mutant (HER2m) metastatic NSCLC (mNSCLC) in the...” PMID 40749900 ↗ Jul 2025 “A Randomized, Open-Label, Phase II Study Comparing the Efficacy and Safety of Trastuzumab-rezetecan and Trastuzumab Deruxtecan (T-DXd) in Neoadjuvant Treatment of Patients With...” NCT07416253 ↗ “PURPOSE: The US Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd) for the treatment of adult patients with unresectable or metastatic...” PMID 36780610 ↗ Feb 2023 |
| Action | Inhibit | “topoisomerase I inhibitor” NCT03368196 ↗ |
| Modality | Other / unclassified | “An antibody drug conjugate” NCT03368196 ↗ |
| Route | Intravenous | “The recommended doses for expansion of 5·4 mg/kg or 6·4 mg/kg trastuzumab deruxtecan were administered intravenously to patients once every 3 weeks until withdrawal of consent,...” PMID 31047803 ↗ Apr 2019 |
| Target | ERBB2 | “target the human epidermal growth factor 2 (HER2) receptor” PMID 35642907 ↗ Aug 2022 |