Fantastic news for people with advanced kidney cancer: the lenvatinib (Kisplyx) plus everolimus (Afinitor) combination 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 the first combination of treatments to be approved for use within the NHS for advanced kidney cancer, and sets a precedence for other drug combinations that are going through the appraisal process. The recommendation of lenvatinib plus everolimus increases the arsenal of drugs available to oncologists, enabling them to select the most effective drug or drug combination 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.

Recommendation of the lenvatinib plus everolimus combination for use within NHS England and Wales allows choice in second-line treatment. This enables patients and oncologists to individualise treatment plans according to specific disease/treatment history and contraindications, thereby enabling the best possible quality of life for the patient.

Previous drug combinations have proven to be unsuccessful as a result of unacceptable side effects. However, the lenvatinib plus everolimus combination seems to be well tolerated, as well as proven to be more effective at extending overall survival compared to single agent therapy with lenvatinib and everolimus. For these reasons, the lenvatinib plus everolimus combination 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, the combination has been fast tracked for approval in a number of countries, including the US and Europe, based on the phase 3 clinical trial data.

Rose Woodward, Founder and Patient Advocate at KCSN, said “This is tremendous news for people with advanced renal cell carcinoma. We have been eagerly awaiting this news from NICE for many months: It will be a great relief to patients and their families to know that their clinicians now have the lenvatinib plus everolimus combination as an effective treatment option in the second line. Kidney cancer is a desperately difficult cancer to treat, and NHS patients need to be confident they can access the latest treatments when they need them. The kidney cancer community is especially grateful that NICE and Eisai have worked together to ensure patients have access to this new clinically effective drug combination.”

NHS England organisations have been instructed to implement this recommendation within 3 months of its publication, while NHS Wales organisations are given 2 months.

KCSN would like to thank those patients and clinicians who contributed to the lenvatinib plus everolimus appraisal – 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 are STRONGER TOGETHER!

See the Eisai press release, where Rose Woodward is quoted!

Take a look at the Final Appraisal Determination document on the NICE website

Read more in the NICE press release, Pharmaphorum and Pharma Times