Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Roche
SCHEDULEDDate confidence: SCHEDULEDGiven as scheduledHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all SCHEDULED pins78% CONFIDENCEOverall confidence: 78%How well the pin's source and references back up its dates.Weighted average of how firmly 4 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or betterin 56 daysRoche's[1] release says "The FDA is expected to make a decision on the approval by 30 November 2026", the PDUFA goal date set under Priority Review.
The FDA is due to decide by 30 November 2026 whether to approve Roche's giredestrant, an oral SERD that cut the risk of recurrence or death by 30% versus standard hormone therapy in early ER-positive breast cancer.
