Posted by Michael Wonder on 21 Feb 2017
NICE draft guidelines reject Ipsen’s Cabometyx
21 February 2017 - NICE has issued its first draft guidelines on Ipsen's Cabometyx, recommending against the drug's routine use on the National Health Service as a treatment for pre-treated advanced renal cell carcinoma.
The drug was cleared by European regulators in September 2016 following an accelerated assessment based on Phase III data showing improvements to overall survival, progression-free survival and objective response rate, and it is currently available to UK patients via a Managed Access Programme.
But NICE's independent appraisal committee concluded that the additional benefits of the drug, when compared with current care, "were highly uncertain as the meta-analysis evidence presented by the company was unreliable," a NICE spokesperson said.
