New Option for Non-Small Cell Lung Cancer Approved

The FDA has approved Brigatinib (alunbrig tablets) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
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Approval of the drug was based on the results of a non-comparative, 2-arm, open-label, multicenter clinical trial involving 222 patients randomly assigned to either oral Brigatinib 90 mg once daily or 180 mg once daily following a 7-day lead-in at 90 mg once daily. The overall response rate was 48% in patients in the 90 mg arm and 53% in those in the 180 mg arm. After a median 8-month follow-up, median duration of response was 13.8 months in both arms.

Safety was evaluated in 219 patients who received at least one dose of Brigatinib in the ALTA trial. The most common adverse events included nausea, diarrhea, fatigue, cough, and headache, and serious adverse reactions included pneumonia and ILD/pneumonitis.

—Michael Potts

Reference:

Brigatinib. FDA Approved Drugs. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm. Published April 28, 2017.