Nivolumab (Opdivo) has been recommended by the National Institute for Health and Care Excellence (NICE) for use by the NHS in England and Wales for people with advanced renal cell carcinoma (RCC) that has been previously treated.

This is fantastic news, and heralds a new era of treatment for kidney cancer patients. The recommendation of nivolumab increases the arsenal of drugs available to oncologists, enabling them to select the most effective drug for individual patients when first-line treatment with targeted therapies fails. This decision also gives hope to many people with advanced kidney cancer, who have come to the end of the line with respect to treatment options routinely funded by the NHS.

Nivolumab is the first immunotherapy to be recommended for kidney cancer, and is a new and innovative class of drug (a PD-1 checkpoint inhibitor) with proven long-term benefits in about one third of cases. Nivolumab has been proven to be a clinically effective and well-tolerated drug, and was designated a breakthrough therapy by the US Food and Drug Administration (FDA) for the treatment of advanced or metastatic RCC. As a breakthrough therapy, nivolumab has been fast tracked for approval in a number of countries, and was previously approved for use under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) in the UK. Nivolumab is already being used by the NHS for the treatment of advanced melanoma patients.

As a breakthrough therapy previously available through EAMS, NHS England organisations have been instructed to implement this recommendation within 30 days of its publication, rather than the usual 90 days for implementation (NHS Wales organisations are given 3 months). However, nivolumab will be available almost immediately, since it will receive interim funding from the Cancer Drugs Fund until the guidelines are implemented.

KCSN would like to thank all those patients who contributed to to the nivolumab appraisal, our original statement, and our response to the Appraisal Consultation Document (ACD), especially the patient experts who attended the appraisal meeting to represent the views and opinions of the wider kidney cancer community, Alison Fielding and Jon Birchall – without your dedication and perseverance on behalf of the kidney cancer community, the decision might not have been so positive – a BIG thank you!

We would also like to thank all the clinicians who fought so hard for access to this innovative new treatment on behalf of their patients. Special thanks goes out to the oncologists who submitted expert clinical opinions at the NICE appraisal meeting, and who highlighted the value of nivolumab in improving survival for people with advanced kidney cancer – we are STRONGER TOGETHER!

Read the NICE press release here and media coverage here.