Celcuity Inc. announced on August 27, 2025, that the U.S. Food and Drug Administration (FDA) agreed to accept its New Drug Application (NDA) for gedatolisib in HR+/HER2- advanced breast cancer for review under the Real-Time Oncology Review (RTOR) program. This program facilitates earlier submission of topline efficacy and safety results, allowing for an earlier start to the FDA’s evaluation.
The company expects to initiate a rolling submission of its NDA for gedatolisib in September, with the completion of the submission targeted for the fourth quarter of 2025. Gedatolisib had previously received both Breakthrough Therapy and Fast Track designations from the FDA, underscoring the urgent need for more effective therapies in this patient population.
The NDA submission is based on the positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial. The gedatolisib triplet reduced the risk of disease progression or death by 76% (HR 0.24), with a median progression-free survival of 9.3 months, an incremental improvement of 7.3 months compared to fulvestrant.
The FDA's decision to include gedatolisib in the RTOR program highlights the drug's potential to demonstrate substantial improvement on a clinically relevant endpoint over available therapies, possess easily interpreted clinical trial endpoints, and have no aspects likely to require a longer review time.
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