Pfizer Inc. (PFE) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending that crizotinib be granted conditional marketing authorization in the European Union, for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.
Crizotinib is an oral, first-in-class, anaplastic lymphoma kinase, or ALK, inhibitor. By inhibiting the ALK fusion protein, crizotinib blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells, which may lead to growth inhibition or regression of tumors.
Mace Rothenberg, senior vice president of the clinical development and medical affairs for Pfizer's Oncology Business Unit, said, "The CHMP's positive opinion brings us 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."
The CHMP's positive opinion will be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Pfizer expects a decision from the Commission in the coming months.
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