EC approves label update for Pfizer’s Xalkori in NSCLC

26 November 2015  •  Author: Victoria White

The European Commission has approved a label update to expand the use of Pfizer’s 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 also been updated to include efficacy data from PROFILE 1014, which demonstrated that the treatment significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens.

“The European Commission’s decision to approve Xalkori in the first-line setting reinforces Xalkori’s role as a standard of care for patients with ALK-positive advanced NSCLC,” said Andreas Penk, MD, regional president Oncology Europe, Africa and the Middle East, Head Greater China and Asia-Pacific Oncology Regions. “This milestone further underscores the importance of early and routine biomarker testing in patients with advanced NSCLC so that these patients can be identified and treated appropriately.”

Xalkori was the first ALK inhibitor approved in the EU

Xalkori is an oral, ALK inhibitor. By inhibiting the ALK fusion protein, the treatment blocks signalling in a number of cell pathways that are believed to be critical for the growth and survival of tumour cells, which may lead to growth inhibition or regression of tumours.

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. Xalkori is widely recognised as a standard of care for patients with ALK-positive advanced NSCLC. To date, more than 20,000 patients have been treated with the drug worldwide.

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