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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 FDA accepted its supplemental New Drug Application for REVTORPYK™ (gedatolisib) to treat patients with HR+/HER2- locally advanced or metastatic breast cancer who have a PIK3CA mutation & have progressed after endocrine therapy.
  • The FDA assigned a Prescription Drug User Fee Act goal date of June 25, 2027, for the review of the application.
  • The submission is based on clinical data from the PIK3CA mutant-type cohort of the Phase 3 VIKTORIA-1 trial.
  • If approved, REVTORPYK would be available as a second-line therapy for the broader HR+/HER2- population regardless of PIK3CA status.
  • REVTORPYK previously received FDA approval on July 14, 2026, for treating HR+/HER2- metastatic breast cancer patients without a detected PIK3CA mutation.
  • Common adverse reactions include stomatitis, rash, & hyperglycemia, with specific warnings regarding severe oral mucositis & fetal harm.
  • Celcuity continues to evaluate REVTORPYK in Phase 3 trials VIKTORIA-2 for first-line treatment & CELC-G-201 for metastatic castration-resistant prostate cancer.