Pfizer has launched Xalkori (crizotinib), its personalised treatment for non-small cell lung cancer (NSCLC), in the UK.
The oral drug is approved in Europe under a conditional licence for patients with previously treated ALK-positive advanced NSCLC patients and it becomes the first specific treatment for this patient subgroup to reach the market.
Pfizer Oncology UK’s medical director Dr David Montgomery said the drug’s launch was a significant milestone for these patients.
“Crizotinib is a new personalised treatment which offers the hope of better outcomes for people with this kind of lung cancer,” he said.
“It demonstrates Pfizer’s commitment to advancing the understanding of the underlying genetic drivers of diseases to help us to better identify people who are most likely to benefit from our treatments.”
Xalkori’s conditional licence was based on study data showing ‘objective response rate’ (defined as complete response plus partial response) of 50 per cent and 61 per cent seen in phase II and phase I trials respectively.
The company hopes to convert Xalkori’s conditional licence into a full one soon and will submit the results of a confirmatory phase III trial to European regulators at the EMA.
The ALK protein controls signalling in a number of cell pathways that are thought to be critical for the growth and survival of cancer cells and Pfizer says preliminary epidemiology suggests that approximately three to five per cent of NSCLC tumours are ALK-positive
However, it is only possible to detect this by testing a sample of a patient’s tumour tissue. Several tests for this are currently available and Pfizer is working with Roche subsidiary Ventana Medical Systems and Cell Signalling Technology to develop its own companion diagnostic for Xalkori.
Lung cancer is the most common cause of cancer death in the UK, accounting for more than a fifth of all cancer deaths. Around 85 per cent of the 41,500 new cases of lung cancer are diagnosed in the UK each year are NSCLC.
Xalkori is expected to be reviewed for cost and clinical effectiveness by the National Institute for Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC) in 2013.