Roche Says Giredrestrant Combination Improved Progression-Free Survival In Phase III Study
Oct 1 (Reuters) - ROCHE HOLDING AG ROPC.S:
ROCHE’S GIREDESTRANT COMBINATION SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL IN ER-POSITIVE ADVANCED BREAST CANCER IN PHASE III EVERA DATA PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE
FDA SETS PDUFA GOAL DATE FOR GIREDRESTRANT ON NOV 30 AND DEC 18, 2026
GIREDRESTRANT COMBINATION SHOWS MANAGEABLE ADVERSE EVENTS WITH NO UNEXPECTED SAFETY FINDINGS
GIREDRESTRANT PLUS EVEROLIMUS REDUCES RISK OF DISEASE PROGRESSION OR DEATH BY 44%-62%
MEDIAN PFS 8.8 MONTHS WITH GIREDRESTRANT PLUS EVEROLIMUS IN ITT POPULATION
OS DATA SHOW POSITIVE TREND IN ITT AND ESR1-MUTATED POPULATIONS
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