FOSTER CITY (dpa-AFX) - Gilead Sciences, Inc. (GILD) said the European Commission has granted marketing authorization for Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate, as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer.
The company noted that the decision is supported by results from the phase 3 ASCENT study, where Trodelvy reduced the risk of death by 49% and improved median overall survival to 11.8 months versus 6.9 months with chemotherapy. The ASCENT study is a global, open-label, randomized phase 3 study that enrolled more than 500 patients across 230 study locations.
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