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Trials & Filings

Pfizer’s Xalkori Gains Full Approval

Breakthrough NSCLC drug confirms results

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The 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.

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 U.S. have increased more than fivefold from 11% before the Xalkori launch to more than 60%, according to Pfizer.

The FDA’s action marks the conversion of an accelerated approval to regular approval and is based on data from the Phase III 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 U.S., Xalkori has received approval in more than 60 countries, including EU, Canada, China, Korea, Japan and Australia.

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