UK – NICE rejects Keytruda for advanced bladder cancer in final guidance

The UK’s National Institute for Health and Care Excellence (NICE) has issued a second final appraisal document rejecting MSD’s Keytruda for the treatment of advanced bladder cancer.

MSD – known as Merck & Co in the US and Canada – had initially been granted authorisation for Keytruda (pembrolizumab) in advanced or metastatic urothelial carcinoma patients who had previously received platinum-based chemotherapy via NICE’s Cancer Drugs Fund in 2018.

As part of the managed access agreement, further evidence could be collected for Keytruda in this indication, which was then reviewed by NICE as part of its final decision.

NICE decided not to issue a permanent recommendation for Keytruda in this patient population in March 2020, after results from the KEYNOTE-045 demonstrated a benefit for overall survival but not for progression-free survival in the second-line setting…