Also known as GDC-9545 and RG6171.
Late‑stage results show divarasib superiority in KRAS G12C NSCLC, giredestrant preserves quality of life while improving efficacy, and Tam‑Peli shows robust activity in nasopharyngeal carcinoma.
evERA Phase III: giredestrant+everolimus doubled median PFS in ESR1‑mutated patients and improved ITT PFS; OS immature; manageable safety; FDA review dates set for Nov 30 and Dec 18, 2026.
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.
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.
