Celcuity Inc. completed the submission of its New Drug Application (NDA) to the U.S. FDA for gedatolisib in HR+/HER2- PIK3CA Wild-Type Advanced Breast Cancer.
The NDA was submitted under the FDA's Real-Time Oncology Review (RTOR) program.
The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.
Milestone Achievement
Submission of NDA for gedatolisib brings the drug closer to availability for patients with advanced breast cancer.
Efficacy Results
Gedatolisib-triplet and gedatolisib-doublet showed significant improvements in progression-free survival compared to fulvestrant.
Mechanism of Action
Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor with a differentiated mechanism of action compared to single-target inhibitors.
- Positive clinical results from Phase 3 VIKTORIA-1 trial established new milestones in HR+/HER2- ABC drug development.
- Gedatolisib demonstrated substantial improvement in progression-free survival and safety profile for advanced breast cancer patients.
The submission of the NDA for gedatolisib marks a crucial step towards providing a potentially practice-changing treatment for patients with HR+/HER2- advanced breast cancer. Celcuity is optimistic about the efficacy and safety of gedatolisib regimens and looks forward to the FDA review process.