FDA grants priority review for supplemental New Drug Application for brigatinib as first-line treatment for anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer

Submission is based on results from phase 3 ALTA-1L trial of brigatinib, a next-generation tyrosine kinase inhibitor, vs crizotinib, which met its primary endpoint, demonstrating superiority in blinded independent review committee assessed progression-free survival.

SPS commentary:

Currently, brigatinib is licensed as monotherapy for the treatment of adult patients with ALK+ advanced non-small cell lung cancer previously treated with crizotinib.


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