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Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

CELC
  • The FDA approved REVTORPYK (gedatolisib) for HR+/HER2- locally advanced or metastatic breast cancer patients without a PIK3CA mutation who progressed after at least one line of endocrine therapy.
  • REVTORPYK is the first & only FDA-approved therapy to inhibit all class I PI3K isoforms (α, β, δ, γ) & mTOR complexes mTORC1 & mTORC2.
  • In the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with palbociclib & fulvestrant reduced the risk of disease progression or death by 76% compared to fulvestrant alone.
  • In the same trial, REVTORPYK combined with fulvestrant reduced the risk of disease progression or death by 67% compared to fulvestrant alone.
  • The REVTORPYK triplet regimen achieved a median progression-free survival of 9.3 months versus 2.0 months with fulvestrant, with an objective response rate of 32% & median duration of response of 17.5 months.
  • The REVTORPYK doublet regimen achieved a median progression-free survival of 7.4 months versus 2.0 months with fulvestrant, with an objective response rate of 28% & median duration of response of 12.0 months.
  • Celcuity anticipates a commercial launch for REVTORPYK in late Q3 2026 & plans to submit a supplemental New Drug Application for PIK3CA-mutated patients in Q3 2026.
  • Common adverse reactions include stomatitis (occurring in 72% with the triplet & 58% with the doublet), rash, hyperglycemia, & hematologic abnormalities.
  • Warnings include severe stomatitis, dermatologic reactions, hyperglycemia, & embryo-fetal toxicity, requiring specific monitoring & contraception measures.
  • A webcast & conference call to discuss the approval will be hosted by Celcuity on Tuesday, July 14, 2026, at 5:30 p.m. EDT.
  • Celcuity is conducting the ongoing Phase 3 VIKTORIA-2 trial to evaluate REVTORPYK in treatment-naive advanced breast cancer patients.