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
June 02, 2026
June 02, 2026
SOUTH SAN FRANCISCO, California, June 2 -- Genentech, a member of Roche Group, issued the following news release:
* * *
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 b . . .
* * *
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 b . . .