Alunbrig, an Oral Kinase Inhibitor, Receives FDA Approval for NSCLC with ALK Mutation

Web Exclusives - FDA Approvals

On April 28, 2017, the FDA approved brigatinib (Alunbrig; Takeda), an oral kinase inhibitor, for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) with ALK mutation whose disease progressed during crizotinib therapy or who are intolerant to crizotinib therapy.

“In recent years, small molecule ALK inhibitors have revolutionized the treatment options for those with advanced ALK+ non-small cell lung cancer. Nevertheless, there is still a need for additional ALK inhibitors like brigatinib (Alunbrig), which have a manageable safety profile and may address mechanisms of clinical resistance,” said David Ross Camidge, MD, PhD, Director of Thoracic Oncology, University of Colorado, Denver.

The approval of brigatinib was based on results from ALTA, a 2-arm, open-label, multicenter, phase 2 clinical trial in which 222 adults with locally advanced or metastatic NSCLC with ALK mutation that progressed during crizotinib therapy received brigatinib 90 mg once daily or 180 mg once daily after a lead-in period with brigatinib 90 mg. All patients had confirmed ALK arrangement based on the Vysis ALK Break Apart FISH Probe Kit test.

The overall response rate was 48% (95% confidence interval [CI], 39-58) in patients who received brigatinib 90 mg and 53% (95% CI, 43-62) in patients who received brigatinib 180 mg. The median duration of response was 13.8 months in the 90-mg group and 13.8 months in the 180-mg group. In patients with measurable brain metastases, the intracranial objective response was 42% in the 90-mg group and 67% in the 180-mg group, with durations of response of not estimable and 5.6 months, respectively.

The most common (≥25%) adverse reactions with brigatinib 180 mg were nausea, diarrhea, fatigue, cough, and headache.

Serious adverse reactions occurred in 38% of patients who received 90 mg of brigatinib and in 40% of patients who received 180 mg of brigatinib, the most common of which included pneumonia and interstitial lung disease/pneumonitis. Fatal adverse reactions occurred in 3.7% of patients.

The recommended starting dose for brigatinib is 90 mg, orally, for the first 7 days; if tolerated, increase to 180 mg.

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Last modified: August 10, 2017
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