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FDA Accelerated Approval of ALUNBRIGTM (brigatinib)

On April 28, 2017 Takeda Oncology announced the FDA approval of ALUNBRIGTM (brigatinib), a kinase inhibitor 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. 

Please read the documents below for detailed information on the FDA approval and the prescribing information:

Approval Information

Prescribing Information