Triple-negative Breast Cancer

• EMA approval · 2025-08-21
  EMA Authorised: Trodelvy (sacituzumab govitecan) — Gilead Sciences Ireland UC

  EMA authorised Sacituzumab govitecan (Trodelvy) for breast cancer, including triple-negative breast cancer, on 5 June 2025, with Gilead Scie…

• FDA approval · 2023-02-03
  FDA Approved: TRODELVY — Supplemental Application (Gilead Sciences, Inc.)

  FDA approves a supplemental application for TRODELVY (sacituzumab govitecan) filed by Gilead Sciences, expanding its approved use.

• FDA approval · 2023-01-06
  FDA Approved: TRODELVY — Supplemental Application (Gilead Sciences, Inc.)

  FDA approves a supplemental application for TRODELVY (sacituzumab govitecan) from Gilead Sciences, expanding the drug's label.

• FDA approval · 2022-06-03
  FDA Approved: TRODELVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for TRODELVY (sacituzumab govitecan) from Gilead Sciences, Inc. The approval reflects action on …

• FDA approval · 2020-04-22
  FDA Approved: TRODELVY — Original Application (Gilead Sciences, Inc.)

  FDA approved TRODELVY (sacituzumab govitecan) under an original Biologics License Application for adults with metastatic triple-negative bre…

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