Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program

Core Viewpoint - Celcuity Inc. announced that the FDA accepted its New Drug Application for gedatolisib in HR+/HER2- advanced breast cancer for review under the Real-Time Oncology Review program, facilitating an earlier evaluation process [1][2] Group 1: FDA Review and Application - The FDA's acceptance of the NDA for gedatolisib is part of the RTOR program, which allows for earlier submission of topline efficacy and safety results [1][3] - Celcuity plans to initiate a rolling submission of its NDA in September 2025, targeting completion by Q4 2025 [1][2] Group 2: Clinical Trial Results - The NDA submission is based on positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial [2] - The gedatolisib-triplet (gedatolisib, fulvestrant, and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median progression-free survival (PFS) of 9.3 months versus 2.0 months for fulvestrant, an improvement of 7.3 months [2] - The gedatolisib-doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67%, with a median PFS of 7.4 months compared to 2.0 months for fulvestrant, an improvement of 5.4 months [2] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumors, with gedatolisib as its lead candidate [4] - Gedatolisib is a potent pan-PI3K and mTORC1/2 inhibitor, differentiating its mechanism of action from other therapies targeting PI3Kα, AKT, or mTORC1 [4] - The company is conducting multiple clinical trials, including the ongoing Phase 1/2 trial for metastatic castration-resistant prostate cancer and the Phase 3 VIKTORIA-2 trial for first-line treatment in HR+/HER2- ABC [4]