NICE U-turn on Novartis' Afinitor for kidney cancer

The UK's National Institute for Health and Care Excellence (NICE) has reversed its previous ruling on Afinitor and is set to recommend the drug for routine NHS use in kidney cancer.

The U-turn on NICE's 2011 decision comes as the regulator continues its reappraisal of all therapies supported by the Cancer Drugs Fund (CDF), with Afinitor (everolimus) previously only available through the scheme.

Now, thanks to new evidence and a confidential discount submitted by Novartis, NICE has backed the drug as a second-line treatment for adults with advanced renal cell carcinoma (RCC) in draft guidance.

Prof Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said: “Advanced renal cell carcinoma is a relatively rare cancer and unfortunately there are limited treatment options for this condition.

“The company engaged positively with the process of reconsidering drugs in the CDF, demonstrated their drug to be cost effective, and as such we were pleased to make a positive recommendation.

“This decision, when implemented, will allow funding in the CDF to be freed up, which can then be spent on other new and innovative cancer treatments.”

A once-daily oral treatment, Afinitor will be available to patients whose disease has progressed during or after six months of treatment with a vascular endothelial growth factor (VEGF-) targeted therapy.

Data from the newly-submitted RECORD-1 trial showed that patients taking Afinitor after VEGF-targeted treatment saw progression-free survival increase by approximately three months, while overall survival was also at least three months more than those in the control group.

Should it receive final approval, Novartis' drug will compete on an even footing with Bristol-Myers Squibb's Opdivo (nivolumab) in the second-line RCC therapy arena, the immunotherapy also having been the subject of a NICE CDF reassessment.

In a recent phase III comparison study, Opdivo was shown to extend overall survival by an average of 5.4 months longer than patients taking Afinitor, with patients also experiencing fewer side effects.