BRIGANIX is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
DOSAGE AND ADMINISTRATION:
90 mg orally once daily for the first 7 days; if tolerated, increase to 180 mg orally once daily.May be taken with or without food.
WARNINGS AND PRECAUTIONS:
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