FDA sets Dec. 18, 2026 PDUFA date for Genentech giredestrant-everolimus NDA
The FDA set a Dec. 18, 2026, PDUFA goal date for Genentech’s NDA for giredestrant with everolimus in advanced breast cancer. The agency also set a Nov. 30, 2026, goal date for giredestrant in early-stage breast cancer.
1. Review dates set
The FDA set a Dec. 18, 2026, PDUFA goal date for Genentech’s NDA covering giredestrant with everolimus for ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer. The agency set a Nov. 30, 2026, goal date for giredestrant in early-stage breast cancer.
