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A hazard ratio of 0.50 (95% CI: 0.37 to 0.68; p<0.0001), from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial, anchors the supplemental New Drug Application Celcuity Inc.
(Nasdaq: CELC) filed with the FDA on August 26, 2026, for REVTORPYK (gedatolisib) in HR+/HER2-, PIK3CA mutant locally advanced or metastatic breast cancer.
The math reconciles: median progression-free survival of 11.1 months on the REVTORPYK-triplet (gedatolisib, fulvestrant, palbociclib) versus 5.6 months on alpelisib plus fulvestrant, consistent with the stated 50% reduction in risk of disease progression or death.
The Minneapolis-based company already holds an FDA approval for REVTORPYK in the same breast cancer indication without the PIK3CA mutation, cleared July 14, 2026.
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