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FDA NewsNewsworthy

Alunbrig a New Treatment Option for Lung Cancer in Patients with ALK Mutation

June 2017 Vol 3 No 3

On April 28, 2017, Alunbrig (brigatinib; from Takeda) became the newest drug to be approved by the FDA for the treatment of metastatic non–small-cell lung cancer (NSCLC) in patients with the ALK mutation whose tumor progressed while receiving crizotinib or patients who cannot use crizotinib. Alunbrig is a kinase inhibitor and comes as pills that are taken orally.

The clinical trial that led to this approval investigated 2 doses of Alunbrig—180 mg and 90 mg; overall, 53% of patients who took the 180-mg tablet had a good response compared with 48% of patients who took the 90-mg tablet, but severe side effects were slightly higher with the higher dose. The recommended starting dose of Alunbrig is 90 mg for the first 7 days; if the patient tolerates this dose, it should be increased to 180 mg.

The most common side effects reported with the 180-mg dose were nausea, diarrhea, fatigue, cough, and headache. Serious side effects occurred in 38% of patients taking the 90-mg tablet and in 40% of patients taking the 180-mg tablet. Pneumonia and lung disease were the most serious side effects. In addition, almost 4% of patients who received this new drug died because of a fatal adverse reaction, mainly related to lung problems and infections.

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Last modified: October 5, 2017