Pfizer initiates rolling submission of crizotinib NDA for ALK-positive advanced NSCLC

Pfizer Inc. announced today that it has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for crizotinib (PF-02341066), an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive. Pfizer expects to complete the submission in the first half of 2011.

"This action represents a significant step in the registration process for crizotinib (PF-02341066). Pfizer is committed to working collaboratively with the FDA as we move forward in the submission process with the ultimate goal of offering a new treatment option for patients with advanced ALK-positive NSCLC," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.

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. Pfizer was granted Fast Track designation by the FDA for crizotinib (PF-02341066) in December 2010. The rolling submission, which is available to medicines that have received Fast Track designation, allows completed portions of the crizotinib (PF-02341066) NDA to be submitted and reviewed by the FDA on an ongoing basis.

Crizotinib (PF-02341066) is an 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, and approximately 3-5 percent of NSCLC tumors are ALK-positive. By inhibiting ALK, crizotinib (PF-02341066) blocks signaling in a number of cell pathways that are critical for the growth and survival of tumor cells. Crizotinib (PF-02341066) is also an inhibitor of c-MET (mesenchymal endothelial transition factor).

Pfizer also plans regulatory submissions to the FDA and the European Medicines Agency for two other investigational oncology compounds in 2011 — axitinib, an oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, for the treatment of patients with metastatic renal cell carcinoma (mRCC), and bosutinib, an oral dual Src and Abl kinase inhibitor, for the treatment of chronic myeloid leukemia (CML).