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Celcuity launches REVTORPYK in the US for breast cancer; drug cuts progression risk by up to 76%
CELCCelcuity Inc.
On September 30, 2026, Celcuity Inc. announced that REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy. The drug was previously approved by the FDA on July 14, 2026, in combination with palbociclib and fulvestrant (triplet) or solely with fulvestrant (doublet). Clinical data from the Phase 3 VIKTORIA-1 trial demonstrated that REVTORPYK reduced the risk of disease progression or death by 76% for the triplet regimen and 67% for the doublet compared to fulvestrant in PIK3CA wild-type patients. The company has launched a patient support program to assist with insurance coverage, reimbursement, and financial assistance. Celcuity Inc. is a biotechnology company focused on developing and commercializing targeted therapies for solid tumor indications.