1 Recommendations

1 Recommendations

1.1 Avelumab with axitinib is recommended for use within the Cancer Drugs Fund as an option for untreated advanced renal cell carcinoma in adults. It is recommended only if the conditions in the managed access agreement for avelumab with axitinib are followed.

1.2 This recommendation is not intended to affect treatment with avelumab plus axitinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Treatment for untreated advanced renal cell carcinoma includes sunitinib, pazopanib, tivozanib or cabozantinib.

Clinical trial evidence shows that, for people with untreated advanced renal cell carcinoma, avelumab plus axitinib increases how long people live without their disease getting worse compared with sunitinib. Early trial results suggest that avelumab plus axitinib also increases how long people with the disease live. But this is uncertain because the final trial results are not available yet. There are no trials comparing avelumab plus axitinib with tivozanib, pazopanib or cabozantinib directly. So, it is uncertain how it compares with these drugs.

Avelumab plus axitinib has the potential to be cost effective, but more evidence is needed:

  • Longer-term follow up of patients in JAVELIN RenalĀ 101 would help to address the uncertainties about how long people live, and how long they live without their disease getting worse.

  • The economic model should reflect the treatment patients in the NHS would have after avelumab plus axitinib.

    Therefore, avelumab plus axitinib is recommended through the Cancer Drugs Fund while further data are collected, and the economic model is updated.

  • National Institute for Health and Care Excellence (NICE)