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Pfizer passes approval in Europe to expand use of XALKORI to first-line treatment of adults with ALK positive advanced non-small cell lung cancer
25 November 2015 -

Healthcare company Pfizer (NYSE:PFE) reported on Wednesday that it has received European Commission approval for a label update to expand use of XALKORI (crizotinib) to first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

The Summary of Product Characteristics has been updated to include efficacy data from PROFILE 1014, which demonstrated that XALKORI significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens.1

According to the company, XALKORI is an oral, ALK inhibitor.3 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 tumors.4,5

This European Commission's approval of XALKORI follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency and is supported by the results from PROFILE 1014, a Phase 3 global, randomized, open-label, two-arm study evaluating the efficacy and safety of XALKORI in patients previously untreated for ALK-positive advanced nonsquamous NSCLC.1

XALKORI was the first ALK inhibitor approved by regulatory authorities in the US, EU, China and Japan and it is now approved in more than 85 countries. It is widely recognized as a standard of care for patients with ALK-positive advanced NSCLC, concluded the company.