for HR+/HER2-/PIK3CA wild-type advanced or metastatic breast cancer
NDA· Priority Review
FDA approved Celcuity's Revtorpyk (gedatolisib) on July 14, 2026 for HR+/HER2-/PIK3CA wild-type locally advanced or metastatic breast cancer — 3 days ahead of the July 17 PDUFA. Distinct from Pfizer's alpelisib (Piqray) which addresses the PIK3CA-mutant subset; Revtorpyk targets the commercially larger wild-type population. Supported by VIKTORIA-1 Phase 3 data. Celcuity's first FDA-approved commercial product.
About
HR+/HER2- breast cancer is a common form of the disease that can spread to bones and other organs, causing pain and difficulty breathing. Revtorpyk (gedatolisib) is a pill that blocks two key proteins, PI3K and mTOR, which cancer cells use to fuel their growth and survival. By shutting down these growth signals, the drug may help control cancer that has progressed after other hormone-based treatments.
Pivotal trial
VIKTORIA-1 Phase 3active not recruitingNCT05501886
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
