Pfizer seeks U.S. FDA, Japanese MHLW approval for crizotinib NDA to treat ALK-positive advanced NSCLC

Pfizer Inc. announced today that its New Drug Application (NDA) for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor, has been accepted for filing and granted Priority Review status by the U.S. Food and Drug Administration (FDA) and has been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW). The proposed indication is for the treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC).

"Our ability to file applications for regulatory review in the U.S. 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.

The FDA's Priority Review status accelerates the review time from 10 months to a goal of six months and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.

Crizotinib received orphan drug designation from the FDA in September 2010 and was granted Fast Track status in December 2010. As a result of the Fast Track designation, Pfizer initiated a rolling submission of crizotinib in January 2011. The FDA's Fast Track process is designed to facilitate development and expedite review of drugs that treat serious or life-threatening diseases and demonstrate the potential to address unmet medical need. In Japan, Pfizer commenced crizotinib clinical trials for patients with ALK-positive advanced NSCLC in March 2010, and crizotinib was granted orphan drug status in January 2011. These filings represent the first simultaneous filings in Japan and the U.S. for a non-Japanese-based pharmaceutical company.

Crizotinib is an investigational oral first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK. Alterations in the ALK gene are believed to be a key driver of tumor development in cancers like NSCLC. The presence of the ALK fusion gene in lung cancer was first reported by a Japanese researcher in 2007. Preliminary epidemiology suggests that approximately 3-5 percent of NSCLC patients have tumors that are positive for the ALK fusion gene. By inhibiting ALK, crizotinib blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells.