FDA Approves Celcuity's Revtorpyk (Gedatolisib) for PIK3CA Wild-Type Breast Cancer

FDA Approves Celcuity's Revtorpyk (Gedatolisib) for PIK3CA Wild-Type Breast Cancer

On July 14, 2026, the U.S. Food and Drug Administration (FDA) approved Celcuity's REVTORPYK™ (gedatolisib) in combination with fulvestrant, with or without palbociclib, for adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer without a PIK3CA mutation (wild-type) whose disease progressed on or after endocrine therapy. REVTORPYK is a first-in-class treatment that inhibits all four class I PI3K isoforms (α, β, δ, γ) as well as mTOR complexes mTORC1 and mTORC2.

The approval was based on the Phase 3 VIKTORIA-1 trial, which demonstrated a massive reduction in the risk of disease progression or death:

• REVTORPYK Triplet (with palbociclib and fulvestrant): Median progression-free survival (PFS) of 9.3 months compared to 2.0 months with fulvestrant alone, representing a 76% risk reduction (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate (ORR) was 32% versus 1% for fulvestrant.
• REVTORPYK Doublet (with fulvestrant): Median PFS of 7.4 months compared to 2.0 months with fulvestrant alone, representing a 67% risk reduction (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR was 28%.

Celcuity plans a commercial launch in late Q3 2026 and expects to submit a supplemental New Drug Application (sNDA) in Q3 2026 to expand the label to include patients with PIK3CA-mutated breast cancer, based on positive mutant cohort data from the VIKTORIA-1 trial presented at the 2026 ASCO Annual Meeting.

"REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2... In the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with palbociclib and fulvestrant and REVTORPYK combined with fulvestrant reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant among patients with PIK3CA wild-type advanced or metastatic breast cancer."

"The PI3K/AKT/mTOR, or PAM, pathway is one of the most important targets in cancer, but comprehensively inhibiting it has stymied researchers and drug developers for nearly two decades. REVTORPYK addressed this 20-year challenge by becoming the first pan-PI3K, mTORC1/2 inhibitor approved by the FDA.¹"