For patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), the FDA has approved brigatinib (ALUNBRIG®, Takeda). In addition, the companion diagnostic for brigatinib, Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) has also been approved. A next-generation ALK inhibitor, brigatinib works by targeting a broad range of ALK mutations.
Approval was based on an open-label, phase 3 trial (NCT02737501) that enrolled 275 patients with locally advanced or metastatic ALK-positive NSCLC with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) who had no prior treatment consisting of ALK inhibitors. Participants were randomized in a 1:1 ratio to receive either 180 mg of brigatinib to be taken once daily (with a 7-day beginning period of 90 mg) or 250 mg twice daily.
The results revealed that progression-free survival was increased in patients who received brigatinib compared with crizotinib (24 months vs 11 months). Brigatinib also improved overall response rate compared with crizotinib (74% vs 62%).
Treatment-related adverse events exhibited in greater than 25% of patients who took brigatinib included diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.
The recommended dose of brigatinib is 90 mg, to be taken orally once daily for the first 7 days. After the initial week, the dose should be increased to 180 mg orally once daily. This medication can be taken with or without food.
For More Information
Alunbrig® (brigatinib) prescribing information (2020). Takeda. Available at: https://www.alunbrig.com/
Clinicaltrials.gov (2020). ALTA-1L study: a phase 3 study of brigatinib versus crizotinib in anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) participants (ALTA-1L). NLM Identifier: NCT02737501.
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