FDA Accepts Ariad’s NDA Filing for Brigatinib

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.