Pfizer (PFE) Gets Conditional Marketing Approval for Crizotinib from CHMP EMA
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Pfizer (NYSE: PFE) that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that crizotinib be granted conditional marketing authorization in the European Union (EU), for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Similar to accelerated approvals in the United States, conditional marketing authorizations in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. If crizotinib is granted conditional marketing authorization, Pfizer will be required to submit data to the EMA from the recently completed PROFILE 1007 study, which the company announced in June met its primary endpoint in previously treated ALK-positive advanced NSCLC patients. Following review of the 1007 results by CHMP, the European Commission would then consider converting the conditional marketing authorization to a normal marketing authorization.
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Similar to accelerated approvals in the United States, conditional marketing authorizations in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. If crizotinib is granted conditional marketing authorization, Pfizer will be required to submit data to the EMA from the recently completed PROFILE 1007 study, which the company announced in June met its primary endpoint in previously treated ALK-positive advanced NSCLC patients. Following review of the 1007 results by CHMP, the European Commission would then consider converting the conditional marketing authorization to a normal marketing authorization.
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