Gilead Sciences received European Commission approval for Trodelvy in combination with Merck’s Keytruda. The therapy is indicated for the first-line treatment of adult patients with metastatic triple-negative breast cancer (TNBC).
This decision marks the first time an antibody-drug conjugate combined with immunotherapy has been authorized for this indication in the European Union. The approval applies to all 27 EU member states, alongside Norway, Iceland, and Liechtenstein.
The treatment is authorized for use regardless of a patient's PD-L1 status. Gilead expects this milestone to establish Trodelvy as a foundational therapy and accelerate the company's oncology sales growth.