FDA grants priority review to sotorasib for lung cancer subset
The FDA granted priority review to sotorasib for treatment of certain patients with non-small cell lung cancer.
The designation applies to use of sotorasib (AMG 510, Amgen) by those with KRAS G12C-mutated locally advanced or metastatic NSCLC who received at least one prior systemic therapy.
An estimated 25,000 people in the United States are diagnosed with KRAS G12C-mutated NSCLC each year.
The FDA based the priority review status on results of the phase 2 CodeBreaK 100 trial, which included 126 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC whose cancer progressed after treatment with chemotherapy and/or immunotherapy.
Patients received 960 mg oral once-daily sotorasib until disease progression.
As Healio previously reported, results showed sotorasib — a KRAS G12C inhibitor — induced a 37.1% overall response rate.
The FDA previously granted breakthrough therapy designation to sotorasib for this indication.
The agency is expected to make a decision on approval by Aug. 16.
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