Gedatolisib FDA Review: HR+/HER2- Breast Cancer & PIK3CA
Gedatolisib NDA Accepted for Review by FDA in Advanced Breast Cancer
Here’s a summary of the key details from the provided text:
What’s happening: The FDA has accepted a New Drug application (NDA) for gedatolisib for the treatment of hormone receptor-positive, HER2-negative advanced breast cancer. This review will be conducted under the Real-Time Oncology Review (RTOR) program.
Key Trial & results (VIKTORIA-1):
The NDA is based on data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial.
Gedatolisib + Fulvestrant + palbociclib significantly improved Progression-Free survival (PFS), reducing the risk of disease progression or death by 76% compared to fulvestrant alone (HR 0.24, p <.0001). Median PFS was 9.3 months vs 2.0 months. Gedatolisib + Fulvestrant also showed a significant PFS benefit, reducing the risk of progression or death by 67% compared to fulvestrant alone (HR 0.33, p < .0001). Median PFS was 7.4 months vs 2.0 months.
Timeline:
Celcuity (the drug developer) plans to begin rolling submission of the NDA in September 2025. Completion of the NDA submission is expected in the fourth quarter of 2025.
Background:
Gedatolisib has previously received Breakthrough Therapy and Fast Track designations.
* VIKTORIA-1 is studying gedatolisib plus fulvestrant (with or without palbociclib) versus fulvestrant alone in patients whose disease has progressed after CDK4/6 inhibitors and aromatase inhibitors.
In essence, this is positive news for patients with this type of breast cancer, as gedatolisib shows promising results in extending progression-free survival and is now being fast-tracked for potential approval.