Posted by Michael Wonder on 20 Apr 2017
Ipsen in talks with NICE over Cabometyx rejection
20 April 2017 - Ipsen says discussions with NICE are ongoing following a second rejection of Cabometyx for 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 in draft guidelines earlier this year NICE's independent appraisal committee concluded that the additional benefits of Cabometyx (cabozantinib), when compared with current care, "were highly uncertain as the meta-analysis evidence presented by the company was unreliable," a NICE spokesperson said.
