Reuters: Regulatory News: Pfizer lung cancer drug gets conditional EU approval

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Pfizer lung cancer drug gets conditional EU approval Oct 24th 2012, 15:30 Wed Oct 24, 2012 11:30am EDT Oct 24 (Reuters) - European health regulators granted conditional approval to Pfizer Inc's Xalkori to treat advanced non-small cell lung cancer in patients with a specific genetic mutation, the company said on Wednesday. The approval had been expected after the European Medicines Agency in July recommended the drug for conditional authorization, which means Pfizer must still submit further data from a recent successful trial. Conditional marketing authorization in Europe is granted to medicines that address unmet medical needs and whose availability would result in a significant public health benefit. Xalkori, known chemically as crizotinib, was approved in the United States last year along with a companion diagnostic to test for the gene mutation known as ALK. The approval was considered an advance in the field of personalized medicine as the genetic test can identify which patients are most likely to benefit from the oral treatment. About 4 percent of patients with the common form of lung cancer are ALK positive, many of them nonsmokers. Following review of data from a successfully completed late stage study, European regulators would consider granting Xalkori full approval, Pfizer said.

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