FDA Accepts Ariad’s NDA Filing for Brigatinib

November 9, 2016

The FDA has accepted for review an NDA for Ariad’s investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, in patients with metastatic ALK-positive non-small cell lung cancer who have progressed on crizotinib.

Ariad’s NDA submission includes clinical data from its Phase I/II and pivotal Phase II trials of brigatinib.

The company plans to submit a marketing authorization application for brigatinib to the European Medicines Agency in early 2017.

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