Genentech's Giredestrant Plus Everolimus Cuts Risk Of Progression Or Death 44% In ITT And 62% In ESR1-Mutated ER-Positive Advanced Breast Cancer In Phase III EvERA; FDA Goal Dates Are Dec. 18 For Advanced Disease And Nov. 30 For Early-Stage Disease

Benzinga · 1d ago
  • Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard endocrine therapy plus everolimus
  • By targeting resistance to endocrine treatments, the giredestrant combination seeks to delay disease progression and improve overall patient outcomes
  • The FDA has set a PDUFA goal date for giredestrant in early-stage breast cancer of November 30, 2026 and in advanced disease of December 18, 2026