FDA Accepts New Drug Application for Roche's Giredestrant in ER-positive Early-stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting
June 02, 2026
June 02, 2026
BASEL, Switzerland, June 2 (TNSxrep) -- Roche, a biotech company, issued the following news release:
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FDA accepts New Drug Application for Roche'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 wi . . .
* * *
FDA accepts New Drug Application for Roche'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 wi . . .