Celcuity receives FDA approval for REVTORPYK (gedatolisib) in HR+/HER2- breast cancer

Celcuity Inc.

FDA approved REVTORPYK for HR+/HER2- PIK3CA wild-type advanced/metastatic breast cancer after endocrine therapy.
Phase 3 VIKTORIA-1: REVTORPYK triplet reduced risk of progression/death by 76% vs fulvestrant (HR=0.24; median PFS 9.3 vs 2.0 months).
Commercial launch expected late Q3 2026; sNDA for PIK3CA mutated cohort planned Q3 2026.
REVTORPYK is the first FDA-approved pan-PI3K/mTORC1/2 inhibitor.
Most common adverse reactions include stomatitis (72% triplet), rash, and hyperglycemia.

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