Gilead Sciences received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its drug Trodelvy. The recommendation supports using Trodelvy in combination with Merck’s Keytruda for a specific form of metastatic triple-negative breast cancer (TNBC).
The endorsement covers first-line treatment for adult patients with unresectable or metastatic TNBC whose tumors express the PD-L1 protein. Data from a Phase 3 study demonstrated that the combination therapy reduced the risk of disease progression or death by 35%.
The European Commission expects to reach a final marketing authorization decision later in 2026. This positive opinion follows a recent EU approval for Trodelvy as a standalone therapy. Approval for the combination would solidify the drug's role as a primary treatment option for this aggressive cancer in Europe.