ARIAD Pharmaceuticals (NASDAQ:ARIA) has completed a rolling NDA submission to the FDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib.
ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib.
The company is seeking accelerated approval for brigatinib and has requested a priority review of the application, which, if granted, would allow for approval of brigatinib in eight months, compared with 12 months for a standard review.
“We are excited that the brigatinib NDA submission is now complete and are hopeful that brigatinib’s data, including the observation of complete responses and activity in the central nervous system, will provide patients and their oncologists with a new treatment option,” Dr. Corey Langer, director of thoracic oncology in the Abramson Cancer Center of the University of Pennsylvania, said in a statement.
ARIAD’s NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib.
ARIAD plans to submit a Marketing Authorization Application for brigatinib to the European Medicines Agency in early 2017.