Pfizer receives EU approval for expanded Xalkori indication

Pfizer's lung cancer therapy Xalkori has been approved in a broader indication by the European Commission.

The regulator has approved a label update to expand use of Xalkori to include the first-line treatment of adults with ALK-positive advanced non-small cell lung cancer (NSCLC).

Moreover, the summary of product characteristics also has been updated to include efficacy data from the PROFILE 1014 trial, which demonstrated that the drug significantly prolonged progression-free survival compared to standard platinum-based chemotherapy regimens.

Dr Andreas Penk, Pfizer's regional president for oncology in Europe, Africa and the Middle East, said: "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 by regulatory authorities in the US, EU, China and Japan, and it is now approved in more than 85 countries.

It is widely recognised as a standard of care for patients with ALK-positive advanced NSCLC, with more than 20,000 patients having been treated with Xalkori worldwide to date.