# FDA Approves Sacituzumab Govitecan as Monotherapy and Combo with Pembrolizumab for Metastatic Triple-Negative Breast Cancer

> fda · REPORTED · 2026-08-05

Supported by progression-free survival outcomes from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials, the FDA approved sacituzumab govitecan-hziy both as a monotherapy and in combination with pembrolizumab for PD-L1-positive metastatic triple-negative breast cancer. The dual approval broadens treatment access for one of the most difficult-to-treat breast cancer subtypes.

About Sacituzumab Govitecan (Gilead/Trodelvy) — sector event: Sacituzumab govitecan is a Trop-2-directed antibody-drug conjugate developed by Gilead Sciences for patients with metastatic triple-negative and other advanced breast cancers who have received prior systemic therapy.

- Company: Sacituzumab Govitecan (Gilead/Trodelvy) — sector event
- Sector: oncology
- Primary source: https://www.pharmacytimes.com/clinical/breast-cancer

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.