Gilead receives positive CHMP opinion for Trodelvy in TNBC

Gilead (GILD) Sciences announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorization of Trodelvy as a monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy. The European Commission decision on the additional Trodelvy indication is anticipated later in 2026. The CHMP’s recommendation is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. Gilead has also submitted an application to the U.S. Food and Drug Administration for approval of Trodelvy in this indication based on the ASCENT-03 study. Gilead has also submitted supplemental filings to the European Medicines Agency and the U.S. Food and Drug Administration for Trodelvy in combination with Keytruda for patients with PD-L1 positive unresectable locally advanced or metastatic TNBC, based on data from the Phase 3 ASCENT-04 study. These applications are currently under review. If approved, Trodelvy has the potential to be a backbone treatment in 1L mTNBC, across PD-L1 status.