Pfizer Wins Expanded Approval for Xalkori in Europe

The European Commission has approved an additional indication for Pfizer’s Xalkori for first-line treatment of adults with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer.

The summary of product characteristics also was updated to include additional efficacy data from the PROFILE 1014 global Phase 3 study, which demonstrated that Xalkori (crizotinib) prolonged progression-free survival in previously untreated patients with ALK-positive advanced nonsquamous NSCLC versus standard chemotherapy regimens.

The oral ALK inhibitor received accelerated approval by the FDA in 2011 for ALK-positive locally advanced or metastatic NSCLC.