Brigatinib Receives Accelerated Approval for Locally Advanced or Metastatic ALK-Positive NSCLC
Based on a noncomparative, two-arm, open-label, multicenter clinical trial demonstrating a clinically meaningful and durable overall response rate, brigatinib (Alunbrig) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) in patients with locally advanced or metastatic ALK-positive non–small cell lung cancer (NSCLC). The indication specifies patients whose disease has progressed or who have become intolerant to crizotinib. All patients had tumors with a documented ALK rearrangement based on an FDA-approved test or a different test with adequate archival tissue to confirm ALK arrangement.
Safety was evaluated in 219 patients who received at least a single dose (90 mg orally once daily) of brigatinib. The most common adverse reactions, occurring in at least 25% of patients, were nausea, diarrhea, fatigue, cough, and headache. The most common serious adverse reactions were pneumonia and interstitial lung disease /pneumonitis.
The FDA previously granted brigatinib Breakthrough Therapy designation for the treatment of patients with ALK-positive NSCLC whose tumors are resistant to crizotinib as well as Orphan Drug designation for the treatment of ALK-positive NSCLC. The FDA granted this application priority review. As a condition of the accelerated approval, Takeda Pharmaceutical Company Limited is required to verify the clinical benefit of brigatinib in a confirmatory trial.