Xalkori (Pfizer) is EU approved conditionally for Non Small Cell Lung Cancer

Pfizer Inc. announced that the European Commission on 23 October 2012 has given conditional marketing authorization for Xalkori (crizotinib) 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. Now that Xalkori has been granted a conditional marketing authorization, Pfizer will be required to submit data to the European Medicines Agency (EMA) from the recently completed PROFILE 1007 study, which was presented in September at the ESMO 2012 Congress in Vienna, Austria. The study met its primary endpoint in previously treated ALK-positive advanced NSCLC patients. Following review of the 1007 results by the EMA�s Committee for Medicinal Products for Human Use (CHMP), the European Commission will consider converting the conditional marketing authorization to a normal marketing authorization.