Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

Celcuity announced FDA approval of REVTORPYK (gedatolisib), the first pan-PI3K and mTORC1/2 inhibitor, for treating HR+/HER2- locally advanced or metastatic breast cancer without PIK3CA mutations. In the Phase 3 VIKTORIA-1 trial, the drug reduced disease progression or death risk by 76% when combined with palbociclib and fulvestrant, and 67% with fulvestrant alone. Commercial launch is anticipated in late Q3 2026.