FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Grants Accelerated Approval to Takeda’s Alunbrig

May 5, 2017
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Takeda’s Alunbrig received accelerated approval from the FDA for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib.

Alunbrig, which previously received a breakthrough therapy designation, is a once-daily oral therapy.

The indication was approved based on tumor response rate and duration. Continued approval may be contingent on a confirmatory trial.

At the recommended dosing regimen, the most common adverse reactions (≥25 percent) with Alunbrig were nausea, diarrhea, fatigue, cough, and headache.

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