Pfizer Files Crizotinib Applications in U.S., Japan

Pfizer’s NDA for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC), has been accepted for filing and granted Priority Review status by the FDA. An application has also been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW).

“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.

Crizotinib is an investigational compound that inhibits the anaplastic lymphoma kinase, or ALK. 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. The compound received orphan drug designation from the FDA in September 2010 and Fast Track status in December 2010.