Sunday - February 22, 2026
FDA Accepts New Drug Application for Roche's Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
February 21, 2026
BASEL, Switzerland, Feb. 21 -- Roche, a biotech company, issued the following news release on Feb. 20, 2026:

* * *

FDA accepts New Drug Application for Roche'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 standard-of-care endocrine t . . .

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