Pfizer receives positive opinion from EMA CHMP for crizotinib to treat ALK-positive NSCLC

Pfizer announced today 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.

"The CHMP's positive opinion brings us a step closer to potentially offering a new personalized treatment to patients with advanced NSCLC across Europe," said Mace Rothenberg, MD, senior vice president of the clinical development and medical affairs for Pfizer's Oncology Business Unit. "This achievement is made possible by our commitment to using knowledge of the underlying genetic drivers of diseases to identify patients most likely to benefit from treatment and to focus our clinical development program on those patients."

The CHMP's positive opinion will be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Pfizer anticipates a decision from the Commission in the coming months.