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Home Industry News Pfizer receives conditional EU approval for cancer drug Xalkori

Pfizer receives conditional EU approval for cancer drug Xalkori

25th October 2012

Pfizer has welcomed news that the European Commission has granted a conditional approval to its new lung cancer therapy Xalkori.

The drug has been ratified for the treatment of adult patients with previously treated anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, based on its positive benefit/risk profile.

Under the conditions of this approval, Pfizer will need to submit data to the European Medicines Agency from the Profile 1007 trial, which recently demonstrated the benefits of Xalkori in a clinical setting.

Following a review of these results by the Committee for Medicinal Products for Human Use, the European Commission will consider converting the conditional marketing authorisation to a standard approval.

Dr Andreas Penk, president of Pfizer Oncology Europe, said: "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."

Earlier this week, Pfizer announced the acquisition of NextWave Pharmaceuticals, a specialist developer of treatments for attention deficit hyperactivity disorder and related central nervous system disorders.ADNFCR-8000103-ID-801475875-ADNFCR

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