Celcuity's REVTORPYK Gets FDA Approval for HR+/HER2- Breast Cancer

Celcuity (CELC) said Tuesday the US Food and Drugs Administration approved REVTORPYK for treating patients with hormone receptor positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, a specific genetic alteration, following progression after endocrine therapy. The approval was based on the Phase 3 VIKTORIA-1 trial, in which median progression-free survival, or time without disease worsening, was 9.3 months with the REVTORPYK triplet combination versus 2.0 months with fulvestrant alone. Celcuity said it anticipates a commercial launch in late third-quarter 2026 and plans to submit a supplemental application to the FDA in the third quarter for the drug in patients with the PIK3CA-mutated form of the disease. The company said REVTORPYK is the first pan-PI3K, mTORC1/2 inhibitor, a drug targeting multiple proteins in a cell-growth pathway, to win FDA approval.