FDA gives regular approval to Pfizer's Xalkori

Drug received accelerated approval from FDA in 2011 due to urgent patient need

NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

Pfizer announced the approval of Xalkori (crizotinib) for anaplastic lymphoma kinase-positive non-small cell lung cancer that has spread to other parts of the body, as detected through testing. Lung cancer causes an estimated 1.4 million deaths around the world each year, according to the International Agency for Research on Cancer. According to Pfizer, more than 6,000 people globally have been treated with Xalkori, including those who received it in clinical trials, while Pfizer estimates that rates of testing for ALK in U.S. lung caner patients are more than 60%.

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


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