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Trodelvy FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 28, 2023.

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, Urothelial Carcinoma

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

  • Trodelvy is indicated for the treatment of adult patients with:
    • Locally Advanced or Metastatic Breast Cancer
      -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.
    • Locally Advanced or Metastatic Urothelial Cancer
      Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor.*
    *This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • 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. Common adverse reactions include neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash and abdominal pain.

Development timeline for Trodelvy

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.