Roche says FDA sets Dec. 18, 2026 PDUFA date for giredestrant in advanced breast cancer
The FDA set a Dec. 18, 2026, PDUFA goal date for Roche’s giredestrant-everolimus application for advanced ER-positive breast cancer. It also set a Nov. 30, 2026, PDUFA date for giredestrant in early-stage ER-positive breast cancer under Priority Review.
1. FDA review dates
The FDA set a Dec. 18, 2026, PDUFA goal date for Roche’s giredestrant-everolimus NDA in advanced ER-positive breast cancer. The agency also set a Nov. 30, 2026, PDUFA date for giredestrant in early-stage ER-positive breast cancer under Priority Review.
