The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the breakthrough immunotherapy, nivolumab, for use in non-small cell lung cancer patients (NSCLC) in England.
The recommendation from NICE will make nivolumab available immediately, via the Cancer Drugs Fund (CDF). Nivolumab will be reimbursed, after chemotherapy, for all patients with locally advanced or metastatic squamous NSCLC and in non-squamous NSCLC patients whose tumours are PD-L1 positive. Going forward, the hope is that nivolumab will be made available to all advanced lung cancer patients as long-term data become available over the next 2 years.
Paul Workman, Chief Executive of The Institute of Cancer Research (London, UK) commented on the announcement: “It’s great news that people in the UK with non-small cell lung cancer will now gain more time with their loved ones after being granted access via the Cancer Drugs Fund to the pioneering immunotherapy nivolumab. I’m pleased to see NICE and the drug’s manufacturer showing flexibility in reaching agreement on the drug’s approval.”
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At the European Society for Medical Oncology (ESMO) congress (8–12th September, Madrid, Spain) unprecedented long-term survival data for nivolumab in patients with previously-treated NSCLC was presented.
At 3 years, nivolumab nearly tripled overall survival in squamous NSCLC [16% (21/135) versus 6% (8/137), HR 0.62; 95% CI: 0.48 to 0.80] and doubled overall survival in non-squamous NSCLC [18% (49/292) versus 9% (26/290), HR 0.73; 95% CI: 0.62 to 0.88] compared to docetaxel. The safety profile of nivolumab remained consistent with that of the initial reports at 3 years, pooled data showed a 10.5% rate of grade 3/4 treatment-related adverse events, with no new safety signals.
Alastair Greystoke from the Freeman Hospital (Newcastle, UK) provided his thoughts on the news: “Today’s decision is a real step forward for advanced lung cancer patients and their families in England. With nivolumab we have a medicine that has been shown in clinical trials to be effective, and has shown promising long-term survival versus standard chemotherapy, in instances where prior chemotherapy has failed.
“Importantly this will now open the door to immunotherapy for more people than ever before. Lung cancer remains a major challenge – currently a high number of people diagnosed with advanced disease in the UK die within one year. With new treatments like nivolumab now available in England, the hope is that we may see this statistic significantly improve in coming years”, he concluded.