Xalkori blocks signaling in a number of cell pathways supposed to be important for the growth and survival of tumor cells, by inhibiting the ALK fusion protein.
With the issuance of the conditional marketing authorization for the product, Pfizer is required to submit the positive data obtained from PROFILE 1007 study to the European Medicines Agency (EMA).
The agency will consider converting conditional marketing authorization to a normal marketing authorization after reviewing 1007 results.
Pfizer Oncology Europe president Dr. Andreas Penk the approval is a significant milestone for adults with ALK-positive advanced NSCLC in Europe.
"XALKORI is a first-in-class medicine and demonstrates Pfizer’s commitment to targeting specific molecular abnormalities and providing the right treatment to the right patient at the right time," Penk added.