Pfizer has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for crizotinib to treat adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Crizotinib, an oral ALK inhibitor, blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells, by inhibiting the ALK fusion protein.
Pfizer oncology business unit, clinical development and medical affairs senior vice president Mace Rothenberg said the CHMP's positive opinion brings a step closer to potentially offering a new personalized treatment to patients with advanced NSCLC across Europe.
"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," Rothenberg added.
Upon the conditional marketing authorization, Pfizer will be required to submit data to the EMA from the PROFILE 1007 study, which 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.
