Gilead Sciences announced that the European Commission (EC) has expanded the marketing authorization for its cancer drug Trodelvy. The new approval is for Trodelvy in combination with Merck's Keytruda to treat adults with a specific type of unresectable or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1. This decision makes the Trodelvy-based regimen the first antibody-drug conjugate plus immunotherapy combination approved for the first-line treatment of this aggressive cancer in the EU.
The approval was supported by data from the Phase 3 ASCENT-04/KEYNOTE-D19 study, which showed the combination significantly reduced the risk of disease progression or death by 35% compared to Keytruda plus chemotherapy. This latest authorization, following a recent EU approval for Trodelvy as a monotherapy for other first-line mTNBC patients, establishes the drug as a backbone therapy for this cancer across PD-L1 status in Europe. Triple-negative breast cancer is an aggressive form with historically poor prognoses.