Pfizer UK 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 label extension covers approximately 3-4% of all NSCLC cases.
This label extension means more UK patients could now be eligible for treatment with crizotinib instead of chemotherapy in the first-line setting. As a personalised medicine, crizotinib allows targeted treatment of a specific group of patients, identified by a biomarker test, who are most likely to benefit.
The approval was granted based on data from the PROFILE 1014 trial, which demonstrated that crizotinib significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens. Patients treated with Xalkori achieved median progression-free survival of 10.9 months versus 7.0 months for chemotherapy.
Rob Day, Pfizer’s director of UK oncology, says: “Approval for expanded use of crizotinib is an important milestone for UK lung cancer patients. It further highlights the importance of early and routine biomarker testing in patients with advanced NSCLC, so we can tailor treatment to these patients.
“An ongoing commitment to investing in diagnostic testing and personalised medicines is essential if the UK is to lead in the discovery of genomic medicines, and continue to provide world-class cancer care in the NHS.”
Crizotinib is currently funded and available to patients living in England via the Cancer Drugs Fund (CDF) as a second or subsequent-line treatment, after first-line combination chemotherapy.
Scottish patients are able to access the treatment in the same indication on the Scottish NHS, after it was accepted by the Scottish Medicines Consortium in October 2013. A month earlier, NICEassessed the same clinical evidence, but did not recommend crizotinib for English and Welsh patients, based on the cost of the drug, despite reductions from Pfizer.
The FDA approved Xalkori- which is co-promoted by Pfizer and Merck- in 2011.