NEW YORK -- The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday recommended approval for Gilead's sacituzumab govitecan (Trodelvy) for previously treated triple-negative breast cancer.
The CHMP opinion, which specifically recommends that sacituzumab govitecan be available in Europe as a monotherapy for TNBC patients who have received two or more systemic therapies, is based on the results of the Phase III ASCENT study, in which sacituzumab govitecan reduced the risk of disease progression or death by 57 percent versus chemotherapy. Patients treated with Gilead's drug had a median progression-free survival of 4.8 months versus 1.7 months among those who received chemo. The median overall survival was 11.8 months versus 6.9 months for patients treated with sacituzumab govitecan and chemo, respectively.
The antibody drug conjugate, which is designed to target Trop-2, a cell-surface protein overexpressed in TNBC, was initially granted US Food and Drug Administration accelerated approval in April 2020. A year later, the agency converted the accelerated approval to a full approval based on additional data. Sacituzumab govitecan is also approved in Australia, Canada, the UK, and Switzerland.
Following the CHMP opinion, the European Commission is expected to reach a final decision on sacituzumab govitecan's marketing authorization later this year.