FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
Genentech's NDA for giredestrant has been accepted by the FDA for ESR1‑mutated, ER‑positive advanced breast cancer, advancing regulatory review toward potential approval and market competition.
Why it mattersFDA acceptance for giredestrant in ESR1-mutated ER-positive advanced breast cancer signals competitors to reassess SERD program timelines.