BioCentury
ARTICLE | Clinical News

Brigatinib regulatory update

June 27, 2016 7:00 AM UTC

Ariad began submission of a rolling NDA to FDA for brigatinib to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients whose tumors are resistant to Xalkori crizotinib. The company said it is seeking accelerated approval of the dual inhibitor of ALK and EGFR and is requesting Priority Review for the NDA. Ariad expects to complete the submission next quarter. ...