The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the Pfizer's Crizotinib will 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.
Crizotinib is an oral, first-in-class, anaplastic lymphoma kinase (ALK) inhibitor. By inhibiting the ALK fusion protein, crizotinib blocks signalling in a number of cell pathways that are believed to be critical for the growth and survival of tumour cells, which may lead to growth inhibition or regression of tumours.
Crizotinib is an investigational agent and has not been approved in the European Union. Crizotinib was first approved as Xalkori in the US in August 2011 for the treatment of locally advanced or metastatic NSCLC that is ALK-positive as detected by a Food and Drug Administration (FDA)-approved test. This indication is based on response rate. There are no data available demonstrating improvements in patient-reported outcomes or survival with Xalkori. Xalkori also has received approval in a number of other countries, including Switzerland, Canada, South Korea and Japan.