FDA Accepts Roche's NDA Seeking Approval for Breast Cancer Drug

Key Takeaways Roche's FDA filing for giredestrant in ER-positive breast cancer accepted, with a Dec. 18, 2026 action date.RHHBY's phase III evERA study showed a 44% lower progression risk in ITT and 62% in ESR1-mutated patients.Roche plans more filings as giredestrant advances across five phase III studies in multiple settings.Roche (RHHBY) announced that the FDA has accepted its new drug application (NDA) for giredestrant, an investigational oral therapy, in combination with everolimus, for the treatment o ...