Celcuity Inc. announced FDA approval of REVTORPYK (gedatolisib) for treating patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer without a PIK3CA mutation following progression on endocrine therapy. The approval is based on Phase 3 VIKTORIA-1 trial results, where the REVTORPYK triplet showed a median progression-free survival of 9.3 months compared to 2.0 months for fulvestrant. The company expects a commercial launch in late Q3 2026 and plans to submit a supplemental New Drug Application in Q3 2026 for the PIK3CA mutated patient population. Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for solid tumor indications.
