(By Balaseshan) Pfizer Inc. (NYSE: PFE) said its non-small cell lung cancer treating drug Xalkori (crizotinib) has received conditional marketing authorization from the European Commission.
Xalkori is a first-in-class medicine used for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Xalkori is an oral, anaplastic lymphoma kinase (ALK) inhibitor. By inhibiting the ALK fusion protein, Xalkori 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.
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.
Xalkori was first approved in the U.S. in August 2011 for the treatment of locally advanced or metastatic NSCLC that is ALK-positive as detected by a U.S. Food and Drug Administration (FDA)-approved test. There are no data available demonstrating improvements in patient-reported outcomes or survival with Xalkori.
Similar to accelerated approvals in the United States, conditional marketing authorizations in the European Union 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.
PFE is trading up 1.07 percent at $25.46 on Wednesday. The stock has been trading between $18.15 and $26.09 over the past 52 weeks.