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European Commission Approves Gilead's Trodelvy for Metastatic TNBC

NEW YORK -- The European Commission on Tuesday approved Gilead's sacituzumab govitecan (Trodelvy) for metastatic or unresectable previously treated triple-negative breast cancer.

Specifically, European regulators have approved the agent as a monotherapy for TNBC patients who have received two or more prior systemic therapies. In reaching the decision, the EC considered results from the Phase III ASCENT study, in which patients receiving sacituzumab govitecan lived a median of 11.8 months, whereas patients treated with a physician's choice of chemotherapy lived for a median of 6.9 months. Median progression-free survival times with the antibody drug conjugate versus chemo were 4.8 months and 1.7 months, respectively. 

The approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use. The Trop-2 directed antibody drug conjugate initially received US Food and Drug Administration accelerated approval in April 2020, and full approval a year later.

Sacituzumab govitecan is also approved for metastatic TNBC in Australia, Canada, the UK, and Switzerland.