Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Monday that the European Commission has approved Trodelvy (sacituzumab govitecan-hziy) with Keytruda (pembrolizumab) for adults with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 with a combined positive score (CPS) of at least 10 and who have not received prior systemic therapy for metastatic disease.

This approval makes Trodelvy the first and only antibody-drug conjugate approved in combination with immunotherapy for first-line metastatic TNBC across the European Union's 27 member states, Norway, Iceland and Liechtenstein.

The decision follows the Commission's recent approval of Trodelvy as a monotherapy for first-line metastatic TNBC patients who are not candidates for PD-1 or PD-L1 inhibitor therapy, positioning Trodelvy as a treatment backbone across PD-L1 status.

The latest approval is based on Phase 3 ASCENT-04/KEYNOTE-D19 data showing statistically significant and clinically meaningful progression-free survival versus standard-of-care chemotherapy plus Keytruda. In the study, Trodelvy reduced the risk of disease progression or death by 35% in patients with PD-L1-positive metastatic TNBC.