Celcuity's REVTORPYK Receives FDA Approval for Breast Cancer

Celcuity Inc. announced that the U.S. Food and Drug Administration (FDA) approved REVTORPYK (gedatolisib) for the treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), locally advanced or metastatic breast cancer without a PIK3CA mutation. REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms and mTOR complexes mTORC1 and mTORC2. The approval is based on positive results from the Phase 3 VIKTORIA-1 trial, where the REVTORPYK triplet reduced the risk of disease progression or death by 76% compared to fulvestrant. Celcuity anticipates commercial launch in late Q3 2026 and plans to submit a supplemental New Drug Application (sNDA) for PIK3CA mutated breast cancer in Q3 2026.