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Trodelvy FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 30, 2024.

FDA Approved: Yes (First approved April 22, 2020)
Brand name: Trodelvy
Generic name: sacituzumab govitecan-hziy
Dosage form: Injection
Company: Gilead Sciences, Inc.
Treatment for: Breast Cancer

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of breast cancer.




Development timeline for Trodelvy

DateArticle
Oct 18, 2024Gilead Announces Plans to Voluntarily Withdraw the U.S. Accelerated Approval for Trodelvy in Metastatic Urothelial Cancer
Feb  3, 2023Approval U.S. FDA Approves Trodelvy in Pre-treated HR+/HER2- Metastatic Breast Cancer
Apr 13, 2021Approval U.S. FDA Grants Accelerated Approval to Trodelvy for the Treatment of Metastatic Urothelial Cancer
Apr  7, 2021Approval FDA Approves Trodelvy, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival
Apr 22, 2020Approval FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer
Apr  7, 2020FDA Grants Fast Track Designation to Sacituzumab Govitecan for Metastatic Urothelial Cancer
Dec 26, 2019Immunomedics Announces FDA Acceptance for Filing of Biologics License Application Resubmission for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer
Feb 20, 2019Immunomedics Announces Publication of Triple-Negative Breast Cancer Data With Sacituzumab Govitecan in the New England Journal of Medicine

Further information

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