Roche: FDA accepts priority‑review NDA for giredestrant in ER‑positive early‑stage breast cancer
- FDA accepted under Priority Review an NDA for oral SERD giredestrant as adjuvant therapy in ER-positive, HER2-negative stage I–III breast cancer; PDUFA date 30 Nov 2026.
- Phase III lidERA (~4,100 patients) showed giredestrant reduced risk of invasive disease recurrence or death by 30% (HR=0.70, 95% CI 0.57-0.87; p=0.0014), with 3-year iDFS 92.4% vs 89.6%.
- Giredestrant safety was manageable with lower treatment discontinuation (5.3%) versus standard-of-care endocrine therapy (8.2%).
- Roche has an NDA for giredestrant plus everolimus in ESR1-mutated advanced ER-positive breast cancer under review (decision expected Dec 2026) and is running five company-sponsored phase III trials.
Regulatory status
FDA accepted Roche’s NDA under Priority Review for oral giredestrant as adjuvant treatment in adults with ER‑positive, HER2‑negative stage I–III breast cancer and set a PDUFA date of 30 November 2026; the FDA also accepted an NDA for giredestrant plus everolimus in ESR1‑mutated advanced ER‑positive disease with a decision expected December 2026.
Phase III lidERA results
The submission is based on the phase III lidERA trial (≈4,100 patients), where adjuvant giredestrant reduced the risk of invasive disease recurrence or death by 30% versus standard‑of‑care endocrine therapy (HR 0.70; 95% CI 0.57–0.87; p=0.0014); three‑year invasive disease‑free survival was 92.4% versus 89.6%.
Safety and follow‑up
Adverse events with giredestrant were reported as manageable; treatment discontinuation was 5.3% versus 8.2% with standard endocrine therapy; overall survival data were immature at the analysis but showed a positive trend and will continue to be followed.
Ongoing clinical programme
Roche’s giredestrant development programme spans multiple settings and includes five company‑sponsored phase III trials (lidERA, evERA, persevERA, pionERA, heredERA); additional analyses from the programme were presented at ASCO 2026.
Source: Roche