Ariad Pharmaceuticals Submits Early NDA for the Approval of Brigatinib. See Also: More News from Ariad

ARIAD Pharmaceuticals (ARIA) announced the initiation of a New Drug Application (NDA) submission for brigatinib, the firm’s investigational anaplastic lymphoma kinase (ALK) inhibitor to the FDA.

Earlier than expected, ARIAD is seeking U.S. marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib, which has received Breakthrough Therapy designation from the FDA for for this NSCLC condition in patients whose tumors are resistant to crizotinib. The FDA has also granted brigatiniborphan drug designation for the treatment of ALK+ NSCLC.

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