The European Commission has expanded the scope of Pfizer’s oral ALK inhibitor Xalkori to include the first-line treatment of adults with a particular form of lung cancer.
The drug was approved back in 2012 to treat adults with previously treated ALK-positive advanced non-small cell lung cancer; its label expansion comes on the back of data showing a progression-free survival benefit also in the first-line setting.
According to results from the Phase III PROFILE 1014 study, patients given Xalkori (crizotinib) had a median progression-free survival of 10.9 months compared to 7 months for those in the chemotherapy arm. Also, the objective response rate was much higher at 74% versus 45%, the firm noted.
ALK gene rearrangements are present in about 5% of NSCLC cancers typically occurring in younger patients who don’t smoke, and Xalkori’s extension means that more patients in the UK could now be eligible for treatment with this targeted drug instead of chemotherapy, Pfizer said.
“Approval for expanded use of crizotinib is an important milestone for UK lung cancer patients,” said Rob Day, Pfizer's Director of UK Oncology, noting that “it further highlights the importance of early and routine biomarker testing in patients with advanced NSCLC, so we can tailor treatment to these patients”.
However, he also stressed that “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”.
In yet another example of the UK’s postcode littering of care, patients in England can only currently get treatment with Xalkori through the Cancer Drugs Fund, after NICE rejected its use for this in England and Wales. However, Scottish patients are able to access the drug after cost regulators accepted its use back in 2013.