The US Food and Drug Administration (FDA) has granted Pfizer’s Xalkori (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.  Xalkori was previously granted accelerated approval in August 2011 due to the critical need for new agents for people living with ALK-positive NSCLC.

Lung cancer is the leading cause of cancer death worldwide with an estimated 1.4 million deaths each year.  To date, globally more than 6,000 patients have been treated with Xalkori, including those who received Xalkori in clinical trials.  ALK testing rates in the US have increased more than 5-fold from 11 per cent before the Xalkori launch to more than 60 per cent.

" Xalkori has dramatically changed the treatment landscape for patients with advanced ALK-positive NSCLC," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. "Achievement of this milestone underscores Pfizer’s commitment to provide physicians with effective cancer therapies for their patients.”

The FDA’s action marks the conversion of an accelerated approval to regular approval and is based on data from the pivotal Phase 3 PROFILE 1007 confirmatory trial comparing Xalkori to standard chemotherapy in previously treated patients.  The results of this study were recently published in the June 20, 2013 issue of the New England Journal of Medicine.

In addition to the US, Xalkori has received approval in more than 60 countries, including EU, Canada, China, Korea, Japan and Australia.