Initial NDA for Investigational ALK Inhibitor Submitted to FDA
Ariad Pharmaceuticals announced the initiation of the first part of a rolling New Drug Application (NDA) submission to the Food and Drug Administration (FDA) for its investigational agent, brigatinib, for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant to crizotinib.
Brigatinib is currently being evaluated in a global Phase 2 trial, which reported positive preliminary results at this year's American Society of Clinical Oncology annual meeting. Data showed that 54% of patients treated with brigatinib 180mg regimen achieved a confirmed objective response; the study's primary endpoint. Brigatinib was found to have a tolerable safety profile. The Company has also initiated a Phase 3 trial to evaluate brigatinib in comparison to crizotinib.
The FDA previously granted brigatinib Breakthrough Therapy designation for the treatment of patients with crizotinib-resistant ALK+ NSCLC and Orphan Drug designation for the treatment of ALK+ NSCLC.
Ariad is seeking accelerated approval and plans to request a priority review for the NDA. The rolling submission will occur in three parts and is expected to be complete in the third quarter of 2016.
Brigatinib is an anaplastic lymphoma kinase (ALK) inhibitor.
For more information visit Ariad.com.