Bristol-Myers Squibb has announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the combination of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) to treat NHS patients in England with renal cell carcinoma (RCC).
This recommendation signifies an important landmark in the treatment landscape representing the first approval of an immuno-oncology combination therapy for first-line patients with this type of cancer in England. Nivolumab and ipilimumab will be immediately available on the Cancer Drugs Fund as a first-line treatment option for previously-untreated intermediate- and poor-prognostic risk advanced RCC, and could be a treatment option for up to 1700 patients each year in England.
“Today’s decision is of importance to advanced kidney cancer patients, who may now have access to more treatment options,” said Rose Woodward, Co-founder of the Kidney Cancer Support Network. “Kidney cancer is a devastating disease and at the most advanced stage prognosis is poor. Having access to this combination therapy on the NHS is therefore an important new addition and a vital step in our fight to extend survival.”
The recommendation is based on data from the Phase III CheckMate 214 study of 1096 patients, which was stopped early after a planned interim analysis showed that the combination of nivolumab and ipilimumab demonstrated superior overall survival compared to sunitinib, a current standard of care.
“It’s very good news that the combination of nivolumab and ipilimumab has now been approved for use in patients with intermediate- and poor risk advanced renal cell carcinoma. A study has demonstrated that this immunotherapy combination is superior to sunitinib in extending overall survival and may now benefit patients whose lives are threatened by a cancer that has increased in incidence by nearly 50% in the last decade,” said Dr Paul Nathan, Consultant Medical Oncologist at Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust.
“We are delighted that NICE has recognised the combination of nivolumab plus ipilimumab as an important treatment option for many patients with advanced RCC. Importantly, the decision may allow intermediate- and poor risk patients in England to receive immunotherapy as a first-line option for the first time,” said Lynelle Hoch, General Manager, Bristol-Myers Squibb UK & Ireland. “Today’s recommendation helps to further our goal of ensuring that increasing numbers of patients will be able to benefit from potentially life-extending medicines.”C
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