Pfizer receives new EU lung cancer approval for Xalkori

Pfizer has announced that its drug Xalkori has been approved in a new lung cancer indication by the European Commission.

The therapy is now indicated for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC), having already been approved as a therapy for anaplastic lymphoma kinase (ALK)-positive forms of the drug.

Positive data from the multicentre single-arm phase I Study 1001, which included patients with ROS1-positive advanced NSCLC treated with 250 mg of Xalkori orally twice daily, was used to support this approval.

This makes Xalkori the only biomarker-driven therapy approved for patients with both ALK-positive and ROS1-positive advanced NSCLC in the EU and the US.

Dr Andreas Penk, regional president for international developed markets at Pfizer Oncology, said: "The European Commission's decision to approve Xalkori for ROS1-positive advanced NSCLC represents an important milestone for patients who previously had limited treatment options."

To date, more than 25,000 patients have been treated with Xalkori worldwide. It is now approved in more than 90 countries.

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