Posted by Michael Wonder on 17 Nov 2025
Celcuity announces completion of submission of its new drug application to the US FDA for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
17 November 2025 - Celcuity today announced the completion of the submission of its new drug application to the US FDA for gedatolisib in hormone receptor positive, human epidermal growth factor receptor 2 negative, advanced breast cancer.
The new drug application was submitted under the FDA’s Real-Time Oncology Review program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both breakthrough therapy and fast track designations based on promising preliminary clinical data.
The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.
