Giredestrant news

All news on Giredestrant (also known as GDC-9545 and RG6171): plants, production capacities, investments and involved companies.

2 June 2026

Roche: FDA accepts priority‑review NDA for giredestrant in ER‑positive early‑stage breast cancer

FDA accepted priority NDA for oral SERD giredestrant as adjuvant in ER‑positive, HER2‑negative stage I–III breast cancer after phase III lidERA showed 30% iDFS risk reduction; PDUFA 30 Nov 2026.
1 June 2026

Genentech: FDA accepts NDA for giredestrant after positive Phase III adjuvant results in early ER‑positive breast cancer

lidERA Phase III: giredestrant reduced invasive recurrence/death by 30% (HR 0.70); 3‑yr iDFS 92.4% vs 89.6%. Priority review; PDUFA Nov 30, 2026; well tolerated in >4,100 pts.

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