FDA Grants Priority Review to Gedatolisib for HR+, HER2-Negative Advanced Breast Cancer

January 29, 2026 Dr. Michael Lee – Health Editor Health

Here’s a breakdown of the key information from the provided text, focusing on efficacy, safety, and regulatory status of⁢ gedatolisib:

Efficacy (VIKTORIA-1 PIK3CA WT cohort):

* PFS (Progression-Free Survival): Significantly improved with both gedatolisib regimens compared to fulvestrant alone.
* Triplet Regimen: Median PFS of 9.3 ⁣months vs. 2 months with fulvestrant (76% risk reduction, HR ⁢0.24, 95% CI 0.17-0.35, P* <.0001)
* Doublet Regimen: Median ⁣PFS of 7.4 months vs. fulvestrant (67% risk reduction, HR 0.33, 95% CI 0.24-0.48, *P < .0001)
* PFS Assessment: Assessed by blinded autonomous central⁤ review.
* ORR (Objective Response Rate): Significantly higher with gedatolisib combinations than with fulvestrant alone.
* significance: The observed effects are considered “unprecedented” in this patient population and may set a‍ new standard for second-line ⁣treatment.
* Secondary Measure: Overall Survival (OS) was also assessed.

Safety & Tolerability:

* Manageable Safety Profile: generally well-tolerated.
* Common Adverse Events: Neutropenia and stomatitis (expected with PAM pathway blockade and CDK4/6 inhibition).
* Hyperglycemia: Notably, clinically important hyperglycemia was not observed.
* discontinuation Rates: Low discontinuation rates ‍due to adverse events, indicating good tolerability.

Regulatory Status:

* Priority review Designation (FDA): Granted, recognizing the potential therapeutic value for HR+/HER2-PIK3CA WT advanced breast cancer. This means faster FDA action on the New Drug Application (NDA).
* Real-Time Oncology Review: The NDA has been accepted ‍into this program, further expediting the review process.

Gedatolisib Mechanism:

* Multi-target inhibitor of all class I PI3K isoforms and both⁤ mTOR complexes (mTORC1 and mTORC2).
* Designed to overcome resistance mechanisms in advanced, endocrine-resistant breast cancer.

Patient Population:

* HR+/HER2-PIK3CA WT advanced breast cancer (a population with significant unmet medical needs).