30 August 2016 - ARIAD Pharmaceuticals today announced it has completed the rolling submission of the new drug application for its investigational anaplastic lymphoma kinase inhibitor, brigatinib, to the U.S. FDA.

ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small-cell lung cancer who are resistant or intolerant to crizotinib. The Company is seeking accelerated approval for brigatinib from the FDA and has requested a priority review of the application, which, if granted, would allow for approval of brigatinib eight months after the NDA submission, as opposed to 12 months for a standard review.

“Many patients with ALK-positive non-small cell lung cancer eventually develop disease progression,” said Corey Langer, M.D., director of thoracic oncology in the Abramson Cancer Center of the University of Pennsylvania and a professor of Hematology-Oncology in Penn’s Perelman School of Medicine. “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.”

Read Ariad Pharmaceuticals press release