Sacituzumab Govitecan Receives Positive CHMP Opinion as 2L Treatment for Adult Patients With Metastatic Triple-Negative Breast Cancer

— Recommendation is Based on the Phase 3 ASCENT Study Showing that Sacituzumab Govitecan Significantly Improved Overall Survival in 2L vs. Physician’s Choice of Chemotherapy in Metastatic Triple-Negative Breast Cancer —

— Sacituzumab Govitecan Could Offer a New Treatment Option for an Aggressive Type of Metastatic Breast Cancer if Approved —

Excerpt from the Press Release:

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 15, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for sacituzumab govitecan as monotherapy indicated for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease. The final European Commission decision on the Marketing Authorization Application for sacituzumab govitecan is anticipated later in 2021.

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. The five-year survival rate for this sub-type is 12%, compared with 28% for other breast cancer types, and these poor outcomes are often coupled with a significant decrease in quality of life, especially in relapsed/refractory disease. Sacituzumab govitecan is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a protein located on the surface of cells and is overexpressed in TNBC and many other tumors.

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