Sacituzumab Govitecan
Monoclonal antibody targets TACSTD2, TOP1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 14 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Her2-receptor negative breast cancer 1 milestone | |||||
| Filed | China (NMPA) | Trodelvy | Her2-receptor negative breast cancer | — | “Regulatory review is also underway in Singapore and China with applications submitted by Everest Medicines.” gilead.com ↗ |
| Filed progesterone-receptor positive breast cancer 2 milestones | |||||
| Filed | EU (EMA) | Trodelvy | progesterone-receptor positive breast cancer | 2023-01-03 | “The European Medicines Agency has also validated a Type II Variation Marketing Authorization Application for Trodelvy in HR+/HER2- metastatic breast cancer.” gilead.com ↗ “Announced that the European Medicines Agency has validated a Type II variation of the Marketing Authorization Application for Trodelvy” gilead.com ↗ “the European Medicines Agency (EMA) has validated a Type II variation Marketing Authorization Application (MAA) for Trodelvy” gilead.com ↗ |
| Filed | US (FDA) | Trodelvy | progesterone-receptor positive breast cancer | 2022-10-11 | “the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Trodelvy” gilead.com ↗ |
| Filed triple-negative breast carcinoma 5 milestones | |||||
| Filed | EU (EMA) | Trodelvy | triple-negative breast carcinoma | 2026-05-22 | “Gilead has submitted a supplemental filing to the European Medicines Agency for Trodelvy in combination with Keytruda ® (pembrolizumab) for patients with PD-L1 positive...” gilead.com ↗ “Gilead has submitted a supplemental filing to the European Medicines Agency for Trodelvy in combination with Keytruda ® (pembrolizumab)” gilead.com ↗ |
| Filed | US (FDA) | Trodelvy | triple-negative breast carcinoma | 2026-05-21 | “Gilead has also submitted supplemental filings to the European Medicines Agency and the U.S. Food and Drug Administration for Trodelvy in combination with Keytruda” gilead.com ↗ “Gilead has also submitted an application to the U.S. Food and Drug Administration for approval of Trodelvy in this indication based on the ASCENT-03 study.” gilead.com ↗ “In the U.S., Gilead has also submitted supplemental filings to the Food and Drug Administration (FDA) for Trodelvy for the first-line treatment” gilead.com ↗ “Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy” gilead.com ↗ “In the U.S., Gilead has also submitted supplemental filings to the Food and Drug Administration (FDA) for Trodelvy” gilead.com ↗ |
| Filed | Other | Trodelvy | triple-negative breast carcinoma | 2021-04-07 | “Regulatory submissions for Trodelvy in metastatic TNBC have been filed in the United Kingdom, Canada, Switzerland and Australia” gilead.com ↗ “Regulatory review is also underway in Singapore and China with applications submitted by Everest Medicines.” gilead.com ↗ |
| Filed | EU (EMA) | Trodelvy | triple-negative breast carcinoma | 2021-04-07 | “European Medicines Agency (“EMA”) validated the Marketing Authorization Application and granted accelerated review for Trodelvy for the treatment of mTNBC.” gilead.com ↗ “The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union.” gilead.com ↗ “the European Medicines Agency validated a Marketing Authorization Application for Trodelvy in March” gilead.com ↗ |
| Filed | UK (MHRA) | Trodelvy | triple-negative breast carcinoma | 2021-04-07 | “Regulatory submissions for Trodelvy in metastatic TNBC have been filed in the United Kingdom, Canada, Switzerland and Australia” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | TRODELVY | — | 2021-04-07 – 2026-06-24 | fda.gov ↗ |
| Approved | EU (EMA) | Trodelvy | — | 2021-11-22 | europa.eu ↗ |
| Approved | US (FDA) | TRODELVY | — | 2020-04-22 | fda.gov ↗ |
Trials 128 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial · 1 met primary | ||||||
| Phase 0 | NCT03995706 | Jul 2019 → Jun 2022 | glioblastoma | The University of Texas Health Science Center at San Antonio | Completed | Met primary |
| Phase 19 trials | ||||||
| Phase 1 | NCT07674615 | Jul 2026 → Jun 2027 expected | fallopian tube carcinoma, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Shanghai Gynecologic Oncology Group | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07163481 | Oct 2025 → Dec 2026 expected | female breast carcinoma | Hunan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06065371 | Nov 2024 → Dec 2026 expected | digestive system cancer | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 1 | NCT05833867 | Apr 2024 → Dec 2026 expected | infiltrating bladder urothelial carcinoma | Shilpa Gupta, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT06167317 | Jan 2024 → Sep 2028 expected | cancer | Gilead Sciences | 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 | NCT05143229 | Mar 2022 → Jan 2025 overdue | breast cancer | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04794699 | Apr 2021 → Jan 2027 expected | cancer | IDEAYA Biosciences | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04617522 | Apr 2021 → Dec 2026 expected | liver failure | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 1/222 trials · 1 missed | ||||||
| Phase 1/2 | NCT07328490 | Apr 2026 | small cell lung carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT06462092 | Jan 2026 → Jan 2027 expected | malignant leptomeningeal tumor | Guangzhou Medical University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07011654 | Sep 2025 → Jul 2028 expected | triple-negative breast carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06926920 | Apr 2025 → Jun 2028 expected | triple-negative breast carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06827613 | Mar 2025 → Jan 2027 expected | hormone receptor-positive breast cancer, triple-negative breast carcinoma | Marengo Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06238921 | Dec 2024 → Feb 2027 expected | triple-negative breast carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06123468 | Apr 2024 → Jan 2026 | gastroesophageal adenocarcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Completed | 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 | 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 | NCT05101096 | Oct 2021 → May 2027 expected | hormone receptor-positive breast cancer, triple-negative breast carcinoma, urothelial carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04826341 | Sep 2021 → Mar 2028 expected | disease of genetic or genomic mechanism, small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04927884 | Sep 2021 → Sep 2022 | triple-negative breast carcinoma | ImmunityBio, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04724018 | May 2021 → Feb 2027 expected | renal pelvis/ureter urothelial carcinoma, urinary bladder cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04863885 | Apr 2021 → Sep 2025 overdue | urothelial carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04381832 | Jul 2020 → Aug 2024 | castration-resistant prostate carcinoma | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04143711 | Nov 2019 → Dec 2025 | cancer | Dragonfly Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT04039230 | Oct 2019 → Jan 2027 expected | breast cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03992131 | Jun 2019 → Mar 2022 | ovarian cancer, triple-negative breast carcinoma, urothelial carcinoma | pharmaand GmbH | Terminated | No outcome recorded |
| Phase 1/2 | NCT03869190 | Jun 2019 → Oct 2025 | urinary bladder cancer, urothelial carcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT01631552 | Dec 2012 → Mar 2019 | cervical cancer, endometrial cancer, esophageal cancer, gastric adenocarcinoma +11 | Gilead Sciences | Completed | No outcome recorded |
| Phase 274 trials · 1 missed | ||||||
| Phase 2 | NCT07504588 | Sep 2026 → Apr 2029 expected | fallopian tube endometrioid adenocarcinoma, fallopian tube serous adenocarcinoma, ovarian endometrioid adenocarcinoma, primary peritoneal serous/papillary carcinoma | National Cancer Institute (NCI) | 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 | NCT07393555 | Aug 2026 → Nov 2028 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07367178 | Jul 2026 → Jun 2027 expected | hormone receptor-positive breast cancer, triple-negative breast carcinoma | MedSIR | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07339059 | Jun 2026 → Feb 2029 expected | small cell lung carcinoma | Bindu R Potugari | Recruiting | No outcome recorded |
| Phase 2 | NCT07492914 | May → Dec 2026 expected | head and neck squamous cell carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07134556 | Apr 2026 → May 2028 | triple-negative breast carcinoma | MedSIR | Withdrawn | No outcome recorded |
| Phase 2 | NCT06889610 | Mar 2026 → Dec 2027 expected | colorectal cancer, melanoma, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07471776 | Mar 2026 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07438600 | Feb 2026 → Feb 2027 expected | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07299409 | Jan 2026 → Aug 2027 expected | triple-negative breast carcinoma | British Columbia Cancer Agency | Recruiting | No outcome recorded |
| Phase 2 | NCT07368543 | Jan 2026 → Jun 2027 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07271992 | Dec 2025 → Dec 2030 expected | triple-negative breast carcinoma | First Hospital of China Medical University | Not yet 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 | NCT07040644 | Sep 2025 → Jun 2027 expected | triple-negative breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07077564 | Jul 2025 → Jul 2027 expected | neuroendocrine neoplasm | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07063212 | Jul 2025 → Jan 2028 expected | hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, nasal cavity cancer, oral cavity squamous cell carcinoma +2 | Memorial Sloan Kettering Cancer Center | 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 | NCT06865677 | Jun → Jul 2025 | cervical carcinoma, endometrial carcinoma, ovarian carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT06401824 | Apr 2025 → Nov 2026 expected | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06923826 | Apr 2025 → Apr 2030 expected | salivary gland cancer, thyroid cancer | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 2 | NCT06665178 | Mar 2025 → May 2027 expected | breast cancer | British Columbia Cancer Agency | 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 | NCT06133517 | Jan 2025 → Jan 2030 expected | infiltrating bladder urothelial carcinoma | Fundación para el Progreso de la Oncología en Cantabria | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06667167 | Dec 2024 → Nov 2027 expected | non-small cell lung carcinoma | Nir Peled | Recruiting | No outcome recorded |
| Phase 2 | NCT06793332 | Dec 2024 → Jan 2026 overdue | metastatic malignant neoplasm in the brain, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06878625 | Dec 2024 → Jun 2027 expected | — | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06528483 | Dec 2024 → Dec 2026 expected | infiltrating bladder urothelial carcinoma | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06682728 | Nov 2024 → Dec 2026 expected | urothelial carcinoma | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 2 | NCT06739395 | Nov 2024 → Dec 2026 expected | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06235216 | Sep 2024 → Dec 2027 expected | differentiated thyroid carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma | Spanish Group for Research in Neuroendocrine Tumors | 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 | NCT06329869 | Aug 2024 → Nov 2026 expected | esophageal squamous cell carcinoma | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06161532 | Aug 2024 → Nov 2027 expected | bladder adenocarcinoma, bladder small cell carcinoma, bladder squamous cell carcinoma, kidney medullary carcinoma +2 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06477419 | Jun 2024 → Jun 2029 expected | pleural mesothelioma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06263543 | Jun 2024 → Jun 2026 overdue | hormone receptor-positive breast cancer | Reshma L. Mahtani, D.O. | Recruiting | No outcome recorded |
| Phase 2 | NCT06462079 | Jun 2024 → Jan 2027 expected | metastatic malignant neoplasm in the brain | Guangzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06248515 | Apr 2024 → May 2027 expected | thymic carcinoma, thymoma | Georgetown University | Recruiting | No outcome recorded |
| Phase 2 | NCT07359404 | Apr 2024 → Dec 2026 expected | breast cancer | YING FAN | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06236269 | Mar 2024 → Feb 2026 overdue | breast cancer | SOLTI Breast Cancer Research Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06055465 | Feb 2024 → Dec 2028 expected | lung cancer | Chinese University of Hong Kong | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06178588 | Feb 2024 → Mar 2026 overdue | hilar cholangiocarcinoma | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06028932 | Jan 2024 → Nov 2026 expected | ovarian carcinoma | Yale University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06100874 | Nov 2023 → Feb 2026 overdue | HER2 positive breast carcinoma, female breast carcinoma | Adrienne G. Waks | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05770531 | Oct 2023 → Aug 2028 expected | triple-negative breast carcinoma | Vanderbilt-Ingram Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05535218 | Sep 2023 → Feb 2027 expected | infiltrating bladder urothelial carcinoma | Claudia Guerrieri | Active not 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 | NCT05884320 | Jul 2023 → Jul 2028 expected | salivary gland cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05332561 | Jun 2023 → Mar 2030 expected | female breast carcinoma | German Cancer Research Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05581589 | Jun 2023 → Oct 2024 | infiltrating bladder urothelial carcinoma | University of Washington | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05601440 | Jun 2023 → Dec 2027 expected | female breast carcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05838521 | Jun 2023 → Jun 2026 overdue | cervical cancer | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT05675579 | May 2023 → Dec 2026 expected | breast cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05633667 | Mar 2023 → Sep 2029 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05520723 | Feb → Oct 2023 | hormone receptor-positive breast cancer, triple-negative breast carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT05327530 | Aug 2022 → Jun 2025 overdue | urothelial carcinoma | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05186974 | May 2022 → Mar 2027 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05226117 | Mar 2022 → Sep 2025 | urothelial carcinoma | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 2 | NCT04559230 | Jan 2022 → Feb 2027 expected | glioblastoma | The University of Texas Health Science Center at San Antonio | Recruiting | No outcome recorded |
| Phase 2 | NCT04958785 | Dec 2021 → Oct 2024 | triple-negative breast carcinoma | Gilead Sciences | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT05119907 | Oct 2021 → Oct 2026 expected | cancer | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04647916 | Jun 2021 → Dec 2027 expected | Her2-receptor negative breast cancer, female breast carcinoma, invasive breast carcinoma, metastatic malignant neoplasm in the brain | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04454437 | Oct 2020 → Aug 2021 overdue | triple-negative breast carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04448886 | Sep 2020 → Mar 2024 overdue | hormone receptor-positive breast cancer, invasive breast carcinoma | Ana C Garrido-Castro, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04468061 | Jul 2020 → Apr 2027 expected | triple-negative breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04230109 | Jul 2020 → Oct 2028 expected | invasive breast carcinoma, triple-negative breast carcinoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04434040 | Jul 2020 → Dec 2026 expected | triple-negative breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04251416 | Mar 2020 → Dec 2026 expected | endometrial carcinoma | Yale University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03964727 | Oct 2019 → Jan 2025 overdue | metastatic neoplasm | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03971409 | Jul 2019 → Jan 2027 expected | female breast carcinoma, invasive breast carcinoma, triple-negative breast carcinoma | Laura Huppert, MD, BA | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03725761 | Oct 2018 → Apr 2024 overdue | prostate cancer | University of Wisconsin, Madison | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03547973 | Aug 2018 → Apr 2030 expected | urothelial carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02161679 | Aug 2016 | triple-negative breast carcinoma | Gilead Sciences | Withdrawn | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06243393 | Apr 2024 → Aug 2028 expected | colorectal cancer | University Hospital Heidelberg | Recruiting | No outcome recorded |
| Phase 318 trials · 5 met primary · 3 missed | ||||||
| Phase 3 | NCT07178730 | Jun 2026 → Mar 2033 expected | triple-negative breast carcinoma | West German Study Group | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06524544 | Dec 2025 → Dec 2030 expected | urothelial carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT06801834 | Apr 2025 → Oct 2029 expected | small cell lung carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT06431633 | Feb 2025 → Nov 2031 expected | non-small cell lung carcinoma | Fundación GECP | Recruiting | No outcome recorded |
| Phase 3 | NCT06081244 | Oct 2024 → Sep 2029 expected | triple-negative breast carcinoma | West German Study Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06486441 | Aug 2024 → Jun 2029 expected | endometrial cancer | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05552001 | Oct 2023 → May 2026 overdue | triple-negative breast carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05840211 | May 2023 → Apr 2028 expected | breast cancer | Gilead Sciences | Active not recruiting | Missed primary |
| Phase 3 | NCT05609968 | Feb 2023 → Jan 2027 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05633654 | Dec 2022 → Jun 2027 expected | triple-negative breast carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT05382286 | Jul 2022 → Feb 2027 expected | triple-negative breast carcinoma | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT05382299 | Jul 2022 → Jul 2028 expected | triple-negative breast carcinoma | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT05089734 | Nov 2021 → Nov 2023 overdue | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | Missed primary |
| Phase 3 | NCT04527991 | Jan 2021 → Jul 2025 | urothelial carcinoma | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT04639986 | Nov 2020 → Dec 2026 expected | breast cancer | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT04595565 | Oct 2020 → Mar 2027 expected | triple-negative breast carcinoma | GBG Forschungs GmbH | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03901339 | May 2019 → Oct 2023 | breast cancer | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02574455 | Nov 2017 → Mar 2020 | breast cancer | Gilead Sciences | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07162259 | Oct 2025 → Dec 2027 expected | breast cancer | Yan Xue | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04319198 | Aug 2020 → Oct 2024 | metastatic neoplasm | Gilead Sciences | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06341478 | Mar 2024 → Mar 2026 overdue | urinary bladder cancer | IRCCS San Raffaele | Recruiting | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 1 | NCT05006794 Background | Sep 2021 → Jun 2025 | cancer | Gilead Sciences | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT06963905 Comparator | Dec 2025 → Dec 2030 expected | triple-negative breast carcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06612203 Background | Jan 2025 → Feb 2027 expected | breast cancer | MedSIR | Active not 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 | NCT07394218 Background | Dec 2025 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06616987 Background | Jul 2025 → Jun 2027 expected | breast carcinoma | Yeon Hee Park | 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 | NCT05008510 Comparator | Dec 2021 → Jul 2022 | triple-negative breast carcinoma | Veru Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT05113966 Background | Dec 2021 → Nov 2023 | triple-negative breast carcinoma | G1 Therapeutics, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04986579 Background | Oct 2021 → Jun 2028 expected | breast cancer, chemotherapy-induced alopecia | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT03606967 Background | Apr 2021 → Dec 2026 expected | invasive breast carcinoma, triple-negative breast carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT07461454 Comparator | Mar 2026 → Dec 2027 expected | breast cancer | MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07533123 Comparator | Mar 2026 → Mar 2029 expected | triple-negative breast carcinoma | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | 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 |
| Phase 3 | NCT04579224 Comparator | Jun 2021 → Aug 2030 expected | urinary bladder carcinoma, urothelial carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06230055 Background | Jan 2024 → Jan 2026 overdue | Her2-receptor negative breast cancer, malignant leptomeningeal tumor | Fudan University | Recruiting | No outcome recorded |
| — | NCT07046455 Background | Mar 2025 → Mar 2027 expected | triple-negative breast carcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| — | NCT04320693 Background | — | triple-negative breast carcinoma | Gilead Sciences | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 54
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | Gilead Sciences | Regulatory European Commission Expands Role of Gilead’s Trodelvy® in First-Line Metastatic Triple-Negative Breast Cancer Across PD-L1 Status gilead.com ↗
Trodelvy plus Keytruda is the first and only antibody-drug conjugate (ADC) plus immunotherapy combination to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein. |
| 2026-07-24 | Gilead Sciences | Regulatory CHMP Recommends Gilead’s Trodelvy® Plus Keytruda® in PD-(L)1-Positive First-Line Metastatic Triple-Negative Breast Cancer gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy ® (sacituzumab govitecan-hziy) in combination with Keytruda ® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10). |
| 2026-06-25 | Merck Sharp & Dohme LLC | Regulatory FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each with Trodelvy® (sacituzumab govitecan-hziy) as First-Line Treatment of PD-L1+ (CPS ≥10) Advanced Triple-Negative Breast Cancer (TNBC) merck.com ↗ |
| 2026-06-24 | Gilead Sciences | Regulatory U.S. FDA Approves Trodelvy® for First-Line Treatment of Metastatic Triple-Negative Breast Cancer gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy ® (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). |
| 2026-06-23 | Gilead Sciences | Regulatory European Commission Approves Trodelvy® as a First-Line Treatment for Metastatic Triple-Negative Breast Cancer Patients Not Candidates for PD-(l)1 Inhibitors gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted marketing authorization for Trodelvy ® (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. |
| 2026-06-08 | Merck Sharp & Dohme LLC | Results Merck and Gilead Provide Update on Phase 3 KEYNOTE-D46/EVOKE-03 Study merck.com ↗
A numerical improvement in PFS was observed, but did not reach statistical significance. |
| 2026-06-08 | Gilead Sciences | Results Merck and Gilead Provide Update on Phase 3 KEYNOTE-D46/EVOKE-03 Study gilead.com ↗
A numerical improvement in PFS was observed, but did not reach statistical significance. |
| 2026-05-22 | Gilead Sciences | Regulatory Gilead Receives CHMP Positive Opinion for Trodelvy® in First-Line Metastatic Triple-Negative Breast Cancer for Patients Not Candidates for PD-(L)1 Inhibitors gilead.com ↗ |
| 2026-01-21 | Gilead Sciences | Results New England Journal of Medicine Publishes Phase 3 ASCENT-04/KEYNOTE-D19 Results Supporting Trodelvy® Plus Keytruda® as a Potential New Standard of Care in First-line PD-L1+ Metastatic Triple-negative Breast Cancer gilead.com ↗
ASCENT-04 successfully met its primary endpoint of progression-free survival (PFS) with a 35% (HR: 0.65; p<0.001) reduced risk of disease progression or death for Trodelvy plus Keytruda (n=221) versus standard of care Keytruda plus chemotherapy (n=222). |
| 2025-11-07 | Gilead Sciences | Results Gilead Provides Update on Phase 3 ASCENT-07 Study gilead.com ↗
Overall survival is a key secondary endpoint and was not mature at the time of the primary analysis; however, an early trend was observed favoring patients treated with Trodelvy compared to chemotherapy. |
| 2025-10-19 | Gilead Sciences | Results Trodelvy® Reduces Risk of Disease Progression or Death by 38% Versus Chemotherapy as First-Line Therapy in Patients With Metastatic Triple-Negative Breast Cancer in ASCENT-03 Study gilead.com ↗
ASCENT-03 successfully met its primary endpoint of PFS with a 38% reduced risk of disease progression or death for Trodelvy versus chemotherapy (HR: 0.62; p<0.0001). |
| 2025-09-08 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Positive Data From Phase 1/2 Combination Trial of IDE397, a potential first-in-class MAT2A inhibitor, and Trodelvy® in MTAP-Deletion Urothelial Cancer ideayabio.com ↗
Overall response rate ( ORR ) of 57% (4/7; 3cPR+1uPR) in patients treated with a combination of 30 mg IDE397 plus 7.5mg/kg Trodelvy ® (Dose level 2); |
| 2025-05-31 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) Plus Trodelvy® (sacituzumab govitecan-hziy) Reduced Risk of Disease Progression or Death by 35% Versus KEYTRUDA Plus Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer (TNBC) merck.com ↗
By combining sacituzumab govitecan with pembrolizumab, we’re seeing meaningful gains in progression-free survival and a promising trend in overall survival—findings that could support a new frontline standard of care for this aggressive disease. |
| 2025-05-31 | Gilead Sciences | Results Trodelvy® Plus Keytruda® Reduces Risk of Disease Progression or Death by 35% Versus Keytruda and Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced Trodelvy ® (sacituzumab govitecan-hziy) plus Keytruda ® (pembrolizumab) reduced the risk of disease progression or death by 35% (HR: 0.65) versus standard of care Keytruda plus chemotherapy in first-line treatment for patients with PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC). |
| 2025-05-23 | Gilead Sciences | Results ASCENT-03: Trodelvy® Demonstrates Highly Statistically Significant & Clinically Meaningful Improvement in Progression Free Survival in Patients With First-line Metastatic Triple-Negative Breast Cancer Who Are Not Candidates for Checkpoint Inhibitors gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ASCENT-03 study of Trodelvy ® (sacituzumab govitecan-hziy). |
| 2025-05-22 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Showcases Innovation in Advanced Cancers and Rare Tumors at ASCO 2025 emdserono.com ↗
When used in the maintenance setting, the combination therapy significantly improved progression-free survival (PFS) versus BAVENCIO alone (HR 0.49 [95% CI, 0.31-0.76]); median PFS was 11.17 months versus 3.75 months, respectively. |
| 2025-05-22 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, Showcases Innovation in Advanced Cancers and Rare Tumors at ASCO 2025 emdgroup.com ↗
When used in the maintenance setting, the combination therapy significantly improved progression-free survival (PFS) versus BAVENCIO alone (HR 0.49 [95% CI, 0.31-0.76]); median PFS was 11.17 months versus 3.75 months, respectively. |
| 2025-05-15 | Kite, A Gilead Company | Results Gilead and Kite Announce Presentation of Transformative Data in 1L Metastatic Triple-Negative Breast Cancer, Updated Results in Multiple Myeloma and Early Data From Novel Investigational CAR T-Cell Therapy Targeting Brain Cancer at 2025 ASCO and EHA kitepharma.com ↗
At ASCO, Gilead will present detailed late-breaking results from the Phase 3 ASCENT-04 study showing a statistically significant and clinically meaningful benefit in progression-free survival for Trodelvy® plus Keytruda® |
| 2025-05-15 | Gilead Sciences | Results Gilead and Kite Announce Presentation of Transformative Data in 1L Metastatic Triple-Negative Breast Cancer, Updated Results in Multiple Myeloma and Early Data From Novel Investigational CAR T-Cell Therapy Targeting Brain Cancer at 2025 ASCO and EHA gilead.com ↗
showing a statistically significant and clinically meaningful benefit in progression-free survival |
| 2025-04-21 | Gilead Sciences | Results Trodelvy® Plus Keytruda® Demonstrates a Statistically Significant and Clinically Meaningful Improvement in Progression Free Survival in Patients With Previously Untreated PD-L1+ Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2024-12-17 | Gilead Sciences | Regulatory U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for Second-Line Treatment of Extensive-Stage Small Cell Lung Cancer gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy ® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. |
| 2024-09-05 | Gilead Sciences | Results Gilead to Present New Trodelvy® Data at the IASLC 2024 World Conference on Lung Cancer gilead.com ↗
These additional findings advance our scientific understanding of the optimal treatment regimens and appropriate patient populations with mNSCLC that may potentially benefit from treatment with Trodelvy in the first-line setting. |
| 2024-05-31 | Gilead Sciences | Results EVOKE-01 Study Results in Metastatic NSCLC to Be Presented at an Oral Session at ASCO 2024 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) today (2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2024-05-30 | Gilead Sciences | Results Gilead Provides Update on Phase 3 TROPiCS-04 Study gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC). |
| 2024-01-22 | Gilead Sciences | Results Gilead Provides Update on Phase 3 EVOKE-01 Study gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC). |
| 2023-10-16 | Kite, A Gilead Company | Results Gilead and Kite Oncology Present Important New Data Across Multiple Difficult-to-Treat Cancers at ESMO Congress 2023 kitepharma.com ↗
Preliminary findings from a clinical collaboration with Dana-Farber Cancer Institute in 2L metastatic urothelial cancer, demonstrated for the first time in any tumor, that potentially two ADCs can be given in combination together. |
| 2023-09-10 | Gilead Sciences | Results Gilead’s Phase 2 EVOKE-02 Study of Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) Demonstrates Promising Clinical Activity in First-Line Metastatic Non-Small Cell Lung Cancer gilead.com ↗
In Cohort A (n=29), confirmed and unconfirmed objective response rate (ORR) was 69%, and disease control rate (DCR) was 86%. |
| 2023-07-27 | Gilead Sciences | Regulatory European Commission Approves Gilead’s Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2023-06-23 | Gilead Sciences | Regulatory Gilead Receives CHMP Positive Opinion for Trodelvy® in Pre-Treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2023-06-05 | Gilead Sciences | Results Trodelvy® Continues to Show Durable Overall Survival Advantage in Pre-Treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗
In this exploratory analysis, Trodelvy demonstrated a clinically meaningful improvement in median OS benefit compared to TPC (median OS: 14.5 months vs. 11.2 months; hazard ratio (HR): 0.79; [95% CI: 0.65-0.95]; nominal p=0.0133). |
| 2023-02-17 | Gilead Sciences | Results Trodelvy® Demonstrates Positive Efficacy Treating Both Platinum-Ineligible and Rapidly Progressing, Post-Platinum Metastatic Urothelial Cancer gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new and updated positive results from three cohorts of the Phase 2 TROPHY-U-01 study of Trodelvy ® (sacituzumab govitecan-hziy) for the treatment of metastatic urothelial cancer (mUC). |
| 2023-02-03 | Gilead Sciences | Regulatory U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has approved Trodelvy ® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. |
| 2023-01-03 | Gilead Sciences | Regulatory European Medicines Agency Validates Marketing Authorization Application For Trodelvy® (sacituzumab govitecan-hziy) For Pre-treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗
The validation of our Marketing Authorization Application in pre-treated HR+/HER2- metastatic breast cancer marks an important step forward to potentially making Trodelvy available to even more patients with severely limited treatment options. |
| 2022-12-06 | Gilead Sciences | Results New Data for Trodelvy Demonstrate Clinical Efficacy Across Trop-2 Expression Levels in HR+/HER2- Metastatic Breast Cancer gilead.com ↗
In the analysis, Trodelvy improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared with TPC across Trop-2 expression levels. |
| 2022-10-11 | Gilead Sciences | Regulatory U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Gilead’s Trodelvy® for Pre-Treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2022-09-07 | Gilead Sciences | Results Trodelvy® Significantly Improved Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in TROPiCS-02 Study gilead.com ↗
In the study, Trodelvy demonstrated a statistically significant and clinically meaningful improvement of 3.2 months in OS compared to TPC (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; [95% confidence interval [CI]: 0.65-0.96]; p=0.02). |
| 2022-09-04 | Gilead Sciences | Results New TROPiCS-02 Data in HR+/HER2- Metastatic Breast Cancer Patients Demonstrates Progression-Free Survival Benefit of Trodelvy® Regardless of Their HER2 Status gilead.com ↗
The analysis examined progression-free survival (PFS) in the intention-to-treat population by HER2-immunohistochemistry (IHC) status, and the results demonstrated that Trodelvy improved median PFS vs. TPC in both HER2-low (IHC1+ and IHC2+/ISH-negative) and IHC0 groups. |
| 2022-08-29 | Gilead Sciences | Results Gilead Demonstrates Strength of Oncology Portfolio Across Diverse Tumor Types at ESMO Congress 2022 gilead.com ↗
Late-Breaking Presentation of Phase 3 TROPiCS-02 Study of Trodelvy ® Demonstrates Overall Survival Benefit in Pre-Treated HR+/HER2- Metastatic Breast Cancer |
| 2022-08-15 | Gilead Sciences | Results Trodelvy® Significantly Improves Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in the TROPiCS-02 Study gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase 3 TROPiCS-02 study evaluating Trodelvy ® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. |
| 2022-06-06 | Gilead Sciences | Results Final Data From Phase 3 ASCENT Study Demonstrates Trodelvy Extends Overall Survival Over Chemotherapy in Second-Line Metastatic TNBC gilead.com ↗
The two-year OS rate was 20.5% (95% CI: 15.4-26.1) in the Trodelvy arm, compared with 5.5% (95% CI: 2.8-9.4) with physicians’ choice of chemotherapy. |
| 2022-06-04 | Gilead Sciences | Results Trodelvy® Improved Progression-Free Survival by 34% in Heavily Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients gilead.com ↗
The study met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003). |
| 2022-03-07 | Gilead Sciences | Results Phase 3 TROPiCS-02 Study Met the Primary Endpoint of Progression-Free Survival in Late-Line HR+/HER2- Metastatic Breast Cancer gilead.com ↗
The study met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy. |
| 2021-12-10 | Gilead Sciences | Results Trodelvy® Demonstrates Clinical Benefit for Black Patients Consistent with Full Metastatic Triple-Negative Breast Cancer Population in ASCENT Study gilead.com ↗
Trodelvy also extended median overall survival to 13.8 months versus 8.5 months with physician’s choice of chemotherapy (HR: 0.64; 95% CI: 0.34-1.19; P=0.159). |
| 2021-11-23 | Gilead Sciences | Regulatory Trodelvy® (sacituzumab govitecan) Granted European Commission Marketing Authorization for Treatment of Metastatic Triple-Negative Breast Cancer in Second Line gilead.com ↗ |
| 2021-11-10 | Gilead Sciences | Results Everest Medicines and Gilead Sciences Jointly Announce Phase 2b Study of Sacituzumab Govitecan Conducted in China of Patients With Metastatic Triple-Negative Breast Cancer Meets Primary Overall Response Rate Endpoint gilead.com ↗
The results demonstrated an ORR of 38.8% (CI: 95%) as evaluated by an Independent Review Committee. |
| 2021-10-15 | Gilead Sciences | Regulatory Sacituzumab Govitecan Receives Positive CHMP Opinion as 2L Treatment for Adult Patients With Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2021-09-27 | Gilead Sciences | Regulatory Gilead Marks Fifth Approval for Trodelvy® in Metastatic Triple-Negative Breast Cancer Under Project Orbis Initiative with Health Canada Authorization gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has approved Trodelvy ® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior therapies, at least one of them for metastatic disease. |
| 2021-09-16 | Gilead Sciences | Results Trodelvy® Significantly Improved Quality of Life Over Standard of Care in 2L+ Metastatic Triple-Negative Breast Cancer in Phase 3 ASCENT Study gilead.com ↗
Trodelvy is not only the first treatment to extend survival in these patients, but this analysis shows it can also significantly lessen the burden of symptoms when quality time is especially important. |
| 2021-09-16 | Gilead Sciences | Results New Data Demonstrate Trodelvy® Survival Benefit in Metastatic Triple-Negative Breast Cancer Patients Regardless of Initial HR/HER2 Status gilead.com ↗
In a retrospective subgroup analysis, Trodelvy improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared with chemotherapy chosen by the patients’ physicians in patients who were not initially diagnosed with TNBC. |
| 2021-06-04 | Gilead Sciences | Results Trodelvy® Demonstrates Superior Outcomes to Standard of Care in Second-Line Treatment of Metastatic Triple-Negative Breast Cancer in Phase 3 ASCENT Study gilead.com ↗
Trodelvy also extended median overall survival to 10.9 months versus 4.9 months with chemotherapy (HR: 0.51; 95% CI: 0.28-0.91). |
| 2021-04-13 | Gilead Sciences | Regulatory U.S. FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy ® (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. |
| 2021-04-07 | Gilead Sciences | Regulatory FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy ® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. |
| 2021-03-25 | Gilead Sciences | Regulatory European Medicines Agency Validates Marketing Authorization Application for Sacituzumab Govitecan-Hziy for the Treatment of Metastatic Triple-Negative Breast Cancer gilead.com ↗
The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation. |
| 2020-12-10 | Gilead Sciences | Results Gilead Advances Oncology Portfolio With New Data From Phase 3 ASCENT Trial of Trodelvy® in Metastatic Triple Negative Breast Cancer gilead.com ↗
The new data and analyses from the ASCENT trial continue to demonstrate the high clinical activity of Trodelvy in this patient population with traditionally poor outcomes. |
All press releases naming this drug 69 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 154 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sacituzumab govitecan | “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 ↗120“Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in hormone receptor-positive human epidermal...” PMID 39354196 ↗ Oct 2024 “Sacituzumab govitecan (brand name: TRODELVY®) is a cancer treatment, called an antibody-drug conjugate, approved in multiple countries for certain types of breast cancer that...” PMID 41277126 ↗ Nov 2025 “BACKGROUND: Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate approved outside Japan for second-line and later metastatic triple-negative breast cancer...” PMID 39302614 ↗ Sep 2024 “antibody-drug conjugates (ADCs) such as sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have demonstrated significant activity in HR+/HER2- breast cancer” NCT07162259 ↗ “Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2-expressing cells and is covalently attached to the topoisomerase I inhibitor SN-38.” NCT06065371 ↗ “TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer” NCT07271992 ↗ “Sacituzumab govitecan is a trophoblast cell-surface antigen 2-directed antibody-drug conjugate approved for certain types of breast cancer.” PMID 41073155 ↗ Sep 2025 “ADC therapy includes sacituzumab govitecan or trastuzumab deruxtecan administered intravenously according to standard dosing schedules.” NCT07394218 ↗ “Sacituzumab govitecan (SG) is a novel antibody-drug conjugate, targeting human trophoblast cell-surface antigen 2 (Trop-2).” PMID 36621000 ↗ Jan 2023 “Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1” NCT06889610 ↗ |
| Known as | hRS7-SN38 | “A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer” NCT01631552 ↗ |
| Known as | HRS7-SN38-ANTIBODY-DRUG-CONJUGATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545262 ↗ |
| Known as | IMMU-132 | “Sacituzumab govitecan (SG), or IMMU-132 is an investigational new drug that utilizes an antibody-drug conjugate (ADC) to target and kill epithelial bladder cancer cells.” NCT05833867 ↗5“A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer” NCT01631552 ↗ “This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132).” NCT05838521 ↗ “* Sacituzumab govitecan (IMMU-132)” NCT04448886 ↗ |
| Known as | Sacituzumab govitecan-hziy | “Sacituzumab govitecan-hziy (SG), the anti-Trop-2 antibody-drug conjugate, resulted in a significant survival benefit over chemotherapy in patients with metastatic...” PMID 35728046 ↗ May 202230“Sacituzumab govitecan-hziy is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan-hziy.” NCT06524544 ↗ “Sacituzumab govitecan-hziy (SG), the anti-Trop-2 antibody-drug conjugate” PMID 35728046 ↗ May 2022 “Sacituzumab Govitecan-hziy (SG)” NCT05089734 ↗ |
| Known as | SG | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04381832 ↗ |
| Known as | Trodelvy | “This arm of the Strata PATH trial will assess the clinical benefit of Trodelvy® (sacituzumab govitecan) in patients with advanced solid tumors and are Trop2 Treatment Response...” NCT05097599 ↗2“Sacituzumab govitecan is an antibody-drug conjugate, comprising a topoisomerase-I inhibiting camptothecin, SN-38, linked to a humanized antibody targeting trophoblastic...” NCT04826341 ↗ “Sacituzumab govitecan (SG; Trodelvy®) is a trophoblast cell-surface antigen 2 (Trop-2)- directed antibody-drug conjugate” NCT07063212 ↗ |
| Action | Deplete | “delivers SN-38 to kill them” NCT03971409 ↗ |
| Action | Inhibit | “DNA topoisomerase I inhibitor” CHEMBL3545262 ↗ |
| Modality | Other / unclassified | “antibody-drug conjugate sacituzumab govitecan” PMID 33093337 ↗ Feb 2021 |
| Route | Intravenous | “Administered via intravenous (IV) infusion” NCT01631552 ↗ |
| Target | TACSTD2 | “delivering targeted cytotoxic effects to TROP2-overexpressing tumor cells” NCT07492914 ↗ |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL3545262 ↗ |