Pfizer files for US and Japanese approval of crizotinib for NSCLC

US drug behemoth Pfizer (NYSE: PFE) says that its New Drug Application for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor, has been accepted for filing and granted Priority Review status by the US Food and Drug Administration and has been filed with the Japanese Ministry of Health, Labor and Welfare (MHLW). The proposed indication is for the treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC).

The drug was fast-tracked by the FDA last December and, assuming approval, will join an NSCLC market sector worth around $4 billion in 2009 and projected by advisory firm Decision Resources to reach $6.5 billion in 2019 and the seven leading countries. The drug also gained orphan drug designation from the US regulator in September last year.

“Our ability to file applications for regulatory review in the USA and Japan simultaneously only three years after beginning worldwide clinical trials in patients with ALK-positive lung cancer is a testament to the hard work of the crizotinib team and the productive discussions that we have had with the respective regulatory agencies. Given the clinical trial results seen to date, we believe that crizotinib, if approved, may change the treatment paradigm for patients with ALK-positive advanced NSCLC,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.