Gedatolisib with Fulvestrant - (VIKTORIA-2)

Aug. 26, 2026: Celcuity (NASDAQ: CELC) announced submission of an sNDA to the FDA for REVTORPYK (gedatolisib) in combination with fulvestrant, with or without palbociclib, for HR-positive/HER2-negative locally advanced or metastatic breast cancer with a PIK3CA mutation after progression on or after at least one line of endocrine therapy.

The filing is supported by the Phase 3 VIKTORIA-1 PIK3CA-mutant cohort. REVTORPYK plus fulvestrant and palbociclib reduced the risk of progression or death by 50% versus alpelisib plus fulvestrant (HR 0.50; 95% CI 0.37–0.68; p<0.0001), with median PFS of 11.1 vs 5.6 months, ORR of 49%, and median DOR of 15.7 months. REVTORPYK plus fulvestrant reduced the risk by 49% (HR 0.51; 95% CI 0.33–0.79; descriptive p=0.0013), with median PFS of 11.3 vs 5.6 months, ORR of 36%, and median DOR of 24.2 months. Safety was described as generally consistent with previously reported VIKTORIA-1 wild-type data.

The company noted REVTORPYK was already FDA approved on July 14, 2026, for HR+/HER2- advanced breast cancer without a PIK3CA mutation in the same post-endocrine-therapy setting. Other ongoing programs mentioned: Phase 3 VIKTORIA-2 in first-line HR+/HER2- advanced breast cancer and Phase 1/2 CELC-G-201 in metastatic castration-resistant prostate cancer.