Trodelvy FDA Approval History
Last updated by Judith Stewart, BPharm on May 13, 2025.
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.
- Trodelvy is indicated for the treatment of adult patients with:
- unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- 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 endocrinebased therapy and at least two additional systemic therapies in the metastatic setting. - The U.S. Food and Drug Administration (FDA) granted accelerated approval for Trodelvy on April 13, 2021 for use in the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who had previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor. On October 18, 2024, Gilead Sciences, Inc. announced plans to voluntarily withdraw the accelerated approval, and on November 22, 2024, the urothelial cancer indication was removed from the product label.
- Trodelvy is administered via intravenous infusion once weekly on Days 1 and 8 of a continuous 21-day treatment cycle. The first Trodelvy infusion is given over 3 hours, with future doses given over 1 to 2 hours if the first dose is tolerated well. Premedication is required to help prevent infusion reactions, and chemotherapy-induced nausea and vomiting.
- The Trodelvy product label carries a boxed warning for severe neutropenia and severe diarrhea. Warnings and precautions include hypersensitivity reactions, severe nausea/vomiting, and embryo-fetal toxicity.
- Common adverse reactions include diarrhea, nausea, fatigue, alopecia, constipation, vomiting, and decreased appetite.
Common laboratory abnormalities include decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, increased glucose, decreased albumin, decreased creatinine clearance, increased alkaline phosphatase, decreased magnesium, decreased potassium, and decreased sodium.
Development timeline for Trodelvy
Further information
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