FDA Grants Priority Review to Celcuity’s Gedatolisib for Advanced Breast Cancer
Event summary
- FDA accepted Celcuity’s NDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer.
- Priority Review designation assigned with a PDUFA goal date of July 17, 2026.
- NDA submission based on Phase 3 VIKTORIA-1 trial data for the PIK3CA wild-type cohort.
- Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor with differentiated mechanism of action.
The big picture
Celcuity’s gedatolisib represents a novel approach to targeting the PI3K/AKT/mTOR pathway, potentially offering a differentiated treatment option for HR+/HER2- advanced breast cancer. The FDA’s Priority Review designation underscores the unmet need in this patient population and the therapeutic potential of gedatolisib. Success in this indication could position Celcuity as a key player in the oncology space, particularly if the drug demonstrates superior efficacy and safety profiles compared to existing therapies.
What we're watching
- Regulatory Timeline
- Whether the FDA will meet the July 17, 2026 PDUFA goal date for gedatolisib’s approval.
- Commercialization Strategy
- How Celcuity plans to position gedatolisib in the competitive HR+/HER2- advanced breast cancer market.
- Clinical Pipeline
- The progress of Celcuity’s ongoing Phase 3 VIKTORIA-2 and Phase 1/2 CELC-G-201 trials.
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