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FDA Accepts New Drug Application for Genentech's Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
February 21, 2026
SOUTH SAN FRANCISCO, California, Feb. 21 -- Genentech, a member of Roche Group, issued the following news release on Feb. 20, 2026:

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FDA Accepts New Drug Application for Genentech's Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer

Filing acceptance based on Phase III data showing giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus sta . . .

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