FDA Approves Trodelvy for First-Line Metastatic Triple-Negative Breast Cancer: Complete Guide to the June 2026 Decision

On June 24, 2026, the FDA approved Trodelvy (sacituzumab govitecan-hziy) for two first-line indications in metastatic triple-negative breast cancer (mTNBC) . The decision expands Trodelvy from a third-line-plus therapy to a front-line backbone for all patients regardless of PD-L1 status, supported by the Phase 3 ASCENT-03 and ASCENT-04 trials . The very next day, the European Commission approved Trodelvy as a first-line monotherapy in Europe . Here is what clinicians, patients, and researchers need to know about this landmark regulatory decision.

The Two Indications Approved by the FDA

The FDA simultaneously approved Trodelvy for two distinct patient populations based on PD-L1 expression:

• Monotherapy: For adults with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1/PD-L1 inhibitors (e.g., PD-L1-negative) .
• Combination with pembrolizumab (Keytruda): For adults whose tumors express PD-L1 (CPS ≥ 10) and who have not received prior systemic therapy for metastatic disease .

These indications mean Trodelvy is now the