Giredestrant
Adjuvant treatment of ER-positive, HER2-negative early breast cancer · Adults with estrogen receptor-positive, HER2-negative stage I, II or III breast cancer
RHHBY · Roche Holdings AG
Regulatory designations
Full timeline
3 milestonesFDA decision expected
FDA assigned a November 30, 2026 PDUFA goal date to the giredestrant NDA for adjuvant treatment of ER-positive, HER2-negative early breast cancer.
Roche — Giredestrant NDA acceptance and PDUFA date↗FDA accepted the NDA with Priority Review
FDA accepted the giredestrant NDA under Priority Review based on the Phase 3 lidERA trial.
Roche — Giredestrant NDA acceptance and Priority Review↗Phase 3 lidERA results supported the filing
In lidERA, adjuvant giredestrant reduced the risk of invasive disease recurrence or death by 30% versus standard endocrine therapy.
Roche — lidERA efficacy results↗Related News
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