Also known as RAD001, Afinitor, and Zortress.
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.
The trial showed significant PFS and ORR improvements with WELIREG and LENVIMA in advanced RCC patients post anti-PD-1/L1 therapy, with consistent safety profiles.
