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Everest Medicines Announces that Licensing Partner Gilead Sciences, Inc. has Received Full US FDA Approval of Trodelvy® for the Treatment of Previously Treated Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Published: 2021-04-09 00:10:00 ET
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Trodelvy® is the first treatment for metastatic triple-negative breast cancer shown to improve progression-free survival and overall survival

SHANGHAI, April 8, 2021 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that the U.S. Food and Drug Administration (FDA) has granted full approval of Trodelvy® (sacituzumab govitecan-hziy) to Gilead Sciences, Inc. (Nasdaq: GILD), a licensing partner of Everest Medicines, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The approval is supported by data from the Phase 3 ASCENT study. In this study, Trodelvy® demonstrated statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p