The FDA has accepted the NDA for gedatolisib under its Real-Time Oncology Review program for HR+/HER2– advanced breast cancer, based on data from the phase 3 VIKTORIA-1 trial in PIK3CA wild-type patients.
In the trial, gedatolisib plus fulvestrant and palbociclib reduced progression risk by 76% compared with fulvestrant alone (HR 0.24; P < .0001), achieving a median PFS of 9.3 vs 2.0 months. The gedatolisib-fulvestrant doublet reduced progression risk by 67% versus fulvestrant monotherapy (HR 0.33; P < .0001) with median PFS of 7.4 vs 2.0 months. VIKTORIA-1 is an open-label study evaluating gedatolisib combinations versus fulvestrant in adults with locally advanced or metastatic HR+/HER2– breast cancer after progression on CDK4/6 inhibitors and aromatase inhibitors. Primary endpoints include progression-free survival, with secondary endpoints assessing overall survival, response rates, and safety.
Celcuity plans to begin rolling NDA submission in September 2025, aiming for completion in Q4 2025. Gedatolisib has received breakthrough therapy and fast track designations, reflecting the urgent need for effective therapies in patients progressing on CDK4/6 inhibitors, according to CEO Brian Sullivan.