UK patients with advanced kidney cancer are being given the opportunity to be treated with Bristol-Myers Squibb’s investigational immunotherapy Opdivo ahead of a licensing decision in Europe.
Opdivo (nivolumab) has been accepted by the Medicines and Healthcare Regulatory Products Agency onto the country’s Early Access to Medicines Scheme for patients with renal cell carcinoma, giving them the chance to access the drug before it is officially approved by regulators.
The drug’s innovative mode of action works by harnessing the ability of the immune system to find and fight cancer, and the decision comes on the back of Phase III clinical trial data showing that a significant median overall survival benefit of 5.4 months compared to standard therapy with Afinitor (everolimus) in patients who received prior therapy.
Kidney cancer is the eighth most common cancer in the UK. Around 27% of kidney cancer patients will have stage IV disease when first diagnosed, of which just 15% of men and 10% of women will survive for five years or more, illustrating a high level of unmet need.
“Nivolumab is the first immunotherapy to demonstrate in a clinical trial significant improvement in kidney cancer survival compared to standard therapy,” noted James Larkin, consultant medical oncologist at The Royal Marsden. “I am very pleased that the MHRA has recognised the life-extending benefit nivolumab can offer to patients with advanced kidney cancer.”
“This is the news patients with advanced kidney cancer have been waiting to hear,” said Nick Turkentine, chief executive of Kidney Cancer UK. “Nivolumab is particularly exciting because it is a new type of treatment for kidney cancer, a monoclonal antibody. Hopefully this new class of cancer drug will lead to more developments in the battle against cancer.”
The news comes just days after the MHRA said that the drug would be available through the EAMS to patients with non-squamous forms of non-small lung cancer, whose tumours express programmed death ligand-1 (PD-L1).