The agency set a Prescription Drug User Fee Act (PDUFA) target action date of June 25, 2027, for its decision, according to Targeted Oncology.
Gedatolisib is a kinase inhibitor of class I PI3K isoforms and mTORC1 and mTORC2. This regulatory submission specifically covers patients whose tumors harbor a PIK3CA mutation and whose disease has progressed on at least one line of endocrine therapy in the metastatic setting.
VIKTORIA-1 Trial Data
Patients in this cohort were assigned to receive either the gedatolisib triplet, the gedatolisib doublet, or alpelisib plus fulvestrant.
The study reported a median progression-free survival (PFS) of 11.1 months for the triplet regimen, compared with 5.6 months for patients receiving alpelisib plus fulvestrant (HR, 0.50; 95% CI, 0.37-0.68; P < .0001).
FDA Approval Granted for Triplet Regimen
That approval, granted on July 14, 2026, followed data showing a 76% reduction in the risk of progression or death for the triplet regimen compared with fulvestrant alone.
If the current sNDA is approved, gedatolisib would be available as second-line therapy regardless of PIK3CA status.
Frequently Asked Questions
What is the status of overall survival data for the PIK3CA-mutant cohort?
Overall survival data were immature at the time of the analysis, and no overall survival values or hazard ratios were reported.
How does the gedatolisib regimen compare to alpelisib in this setting?
In the VIKTORIA-1 trial, the objective response rate was 48.9% for the gedatolisib triplet, 35.7% for the gedatolisib doublet, and 26.0% for alpelisib plus fulvestrant. The median duration of response was 15.7 months for the triplet, 24.2 months for the doublet, and 7.5 months for alpelisib plus fulvestrant.
Will gedatolisib be limited to PIK3CA-mutant patients if approved?
The drug is already approved for patients without the PIK3CA mutation. This new application seeks to extend that indication to include the PIK3CA-mutant population, which would make the therapy available for this subset after progression on endocrine therapy.
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