ODINSIGNAL JOURNAL · NEWS & EVENTS
FDA decision on Roche’s giredestrant‑everolimus for advanced breast cancer set for Dec 18 2026
Roche’s giredestrant plus everolimus for ER‑positive advanced breast cancer has a PDUFA target date of December 18 2026, pending FDA review.
At a glance
- Date
- 2026-12-18
- Participants
- Roche Holding AG ADR
Roche Holding AG’s oral estrogen‑receptor degrader giredestrant, combined with the mTOR inhibitor everolimus, is slated for an FDA decision on December 18 2026. The PDUFA calendar lists the application for ER‑positive, HER2‑negative, ESR1‑mutated metastatic breast cancer with that target date, though the agency may act earlier or extend the deadline — see the PDUFA calendar. The target date was disclosed in a Genentech press release on February 19 2026 and appears in the evERA PDUFA entry, which records the target as 2026‑12‑18. As of today (Nov 7 2026) no outcome has been announced; the date remains a goal rather than a guarantee.
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