- ARIAD Pharmaceuticals (NASDAQ:ARIA) initiates the rolling submission of its New Drug Application (NDA) to the FDA seeking approval of Breakthrough Therapy- and Orphan Drug-tagged brigatinib for the treatment of patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to Pfizer's (PFE) XALKORI (crizotinib). The company will request accelerated review of the filing, expected to be completed in Q3.
- Brigatinib is an oral inhibitor of an enzyme called anaplastic lymphoma kinase (ALK). The abnormal expression of ALK is a key driver of certain types of non-small cell lung cancer, neuroblastomas and anaplastic large cell lymphoma. It is not generally expressed in normal adult tissues so it is a promising therapeutic target.
- Update: On August 30, the company announced the completion of the submission.