FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting
Filing acceptance, under priority review, based on Phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy
Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years
Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early-stage (I-III)
The FDA has set a Prescription Drug User Fee Act date of November 30, 2026
