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Trodelvy Approval History

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

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate for the treatment of patients with previously-treated metastatic triple-negative breast cancer (mTNBC).

Development History and FDA Approval Process for Trodelvy

DateArticle
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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