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FDA Upgrades Approval for Pfizer’s Xalkori

November 21, 2013

The FDA has granted “regular” approval for Pfizer’s lung cancer drug Xalkori after conditionally approving it in August 2011 under the agency’s accelerated approval program.

The Wednesday decision was based on data from a multinational, randomized, open-label and active-controlled trial of 347 patients who were either treated with Xalkori (crizotinib) or chemotherapy. Results showed that patients with metastatic non-small cell anaplastic lymphoma kinase-positive lung cancer taking Xalkori survived without progression of disease for an average of 7.7 months — nearly five months longer than patients in the chemotherapy arm.

The drug was initially approved based on “durable, objective response rates of 50 percent and 61 percent in two single-arm, open-label studies,” the FDA said.

The European Medicines Agency conditionally approved Xalkori in October 2012. — Lena Freund

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