Newly FDA-Approved REVTORPYK Included in NCCN Clinical Practice Guidelines for HR+/HER2- Breast Cancer

Celcuity Inc. announced that its newly FDA-approved drug, REVTORPYK™ (gedatolisib), has been recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®). REVTORPYK, in combination with fulvestrant, with or without palbociclib, is now a preferred Category 1 second-line or subsequent-line therapy for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer without a PIK3CA mutation, following progression on or after at least one line of endocrine therapy. REVTORPYK received FDA approval on July 14, 2026.