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Celcuity Announces FDA Acceptance of sNDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

CELC
  • Celcuity Inc. announced that the U.S. FDA accepted its supplemental New Drug Application (sNDA) for REVTORPYK™ (gedatolisib) to treat HR+/HER2- locally advanced or metastatic breast cancer patients with a PIK3CA mutation following progression on endocrine therapy.
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 25, 2027, for the review of this application.
  • The submission is based on clinical data from the PIK3CA mutant-type cohort of the Phase 3 VIKTORIA-1 trial, where gedatolisib previously received Breakthrough Therapy & Fast Track designations.
  • If approved, REVTORPYK would become available as second-line therapy for a broader population regardless of PIK3CA status, expanding beyond the current approval for patients without the mutation.
  • REVTORPYK received initial FDA approval on July 14, 2026, for use in combination with fulvestrant (with or without palbociclib) for patients without a detected PIK3CA mutation.
  • The drug is a kinase inhibitor of class I PI3K isoforms & mTOR complexes designed to inhibit the PI3K/AKT/mTOR pathway.
  • Common adverse reactions include stomatitis, rash, hyperglycemia, & hematologic abnormalities, with specific warnings regarding severe stomatitis, dermatologic reactions, & embryo-fetal toxicity.
  • Celcuity is also conducting the Phase 3 VIKTORIA-2 trial for first-line treatment & the Phase 1b/2 CELC-G-201 trial for metastatic castration-resistant prostate cancer.
Company
Celcuity Inc.
Keywords
Nasdaq:CELC, Celcuity Inc., Celcuity, CELC, gedatolisib, HR+/HER2- breast cancer, REVTORPYK