pharmafileApril 11, 2019
NICE has revealed it is recommending that Bristol-Myers Squibb’s Opdivo (nivolumab), in combination with Yervoy (ipilimumab), be made available to patients in England via the Cancer Drugs Fund (CDF) for the first-line treatment of untreated renal cell carcinoma (RCC), the most common form of kidney cancer.
The drug’s immediate availability through this new pathway provides RCC with another treatment option, which is particularly meaningful as current NHS standard of treatment such as pazopanib, sunitinib, tivozanib or cabozantinib are associated with side-effects including hand and foot syndrome and fatigue.
The decision was based on Phase 3 data derived from 1,096 patients. The trial was stopped early once it was established that BMS’ drug combo proved itself superior to sunitinib in extending overall survival.
In the UK, RCC is the seventh most common form of cancer, with rates having risen 47% in approximately the last ten years. There were more than 12,500 diagnoses of the disease in 2015, which kills around 4,500 people in the UK every year, particularly as between 25% and 31% of UK patients were diagnosed at an already advanced stage, with only 5% surviving stage 4 forms for five years or more.
"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."
Lynelle Hoch, General Manager at BMS UK & Ireland, commented: "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."
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