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
Breast cancer starts in breast tissue and can cause a lump, skin changes, or nipple discharge, and when it spreads it may bring bone pain, swollen lymph nodes, or breathing trouble. Revtorpyk is a pill that blocks two growth signals inside cancer cells, PI3K and mTOR, which normally tell those cells to keep dividing. Because this drug shuts down both signals at once, it may help slow tumor growth in people whose cancer has worsened after earlier hormone-based treatment.
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.
