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A conditional marketing authorization is renewable annually. The European Commission will consider converting it to a standard marketing authorization after Pfizer submits data from a recent trial to the European Medicines Agency.
Xalkori was approved in the U.S. in 2011 and has been approved in countries including Switzerland, Canada, South Korea, and Japan. Pfizer has submitted it for regulatory review in several other countries.
According to Pfizer: 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 tumor.