FDA approves sacituzumab govitecan as first‑line therapy for metastatic triple‑negative breast cancer

The U.S. Food and Drug Administration (FDA) has approved the antibody‑drug conjugate sacituzumab govitecan (brand name Trodelvy) for first‑line treatment of metastatic triple‑negative breast cancer (mTNBC). The approval covers use as a single agent for patients who cannot receive PD‑1/PD‑L1 inhibitors and as a combination with pembrolizumab for tumours that are PD‑L1 positive (Combined Positive Score ≥ 10). The decision is based on the results of large phase‑III trials ASCENT‑03 and ASCENT‑04/KEYNOTE‑D19, which demonstrated clinical benefit. Sacituzumab govitecan targets the surface antigen Trop‑2, which is over‑expressed in most TNBC cases, marking a shift from the previous reliance on chemotherapy alone.