Brief: FDA Accepts NDA For Roche's Giredestrant In ER-Positive Early-Stage Breast Cancer
02/06/2026 06:02
BRIEF-FDA Accepts NDA For Roche's Giredestrant In ER-Positive Early-Stage Breast Cancer June 2 (Reuters) - Roche Holding AG ROPC.S:
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
ROCHE HOLDING AG - FDA SETS PDUFA DATE FOR GIREDRESTRANT DECISION AS NOV 30, 2026
ROCHE HOLDING AG - PHASE III DATA SHOW GIREDRESTRANT REDUCES RISK OF DISEASE RECURRENCE OR DEATH BY 30%
ROCHE HOLDING AG - 92.4% OF GIREDRESTRANT PATIENTS ALIVE AND DISEASE-FREE AT 3 YEARS VERSUS 89.6% FOR SOC
Source text: ID:nGNE2cp2kZ
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