FDA advisory panel back Merck & Co.’s Keytruda treatment for bladder cancer

pharmafile | December 18, 2019 | News story | Research and Development FDA, Merck, Merck and Co, NHS, NICE, keytruda 

An FDA advisory committee voted 9 to 4 in favour of recommending Merk and Co’s Keytruda (pembrolizumab) for treatment in patients with high-risk, non-muscle-invasive bladder cancer (NMIBC).

The FDA is expected to reach a decision, based on a priority review, in January 2020.

The vote was taken after a Phase 2 trial of 102 patients with high-risk NMIBC. An analysis of the study’s primary endpoint showed a complete response rate of 38.8% at three months in patients whose disease was unresponsive to Bacillus Calmette-Guérin (BCG) therapy, and who were ineligible for, or who refused to undergo, radical cystectomy.

Roy Baynes, Head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories, said: “Patients currently have limited non-surgical treatment options approved by the FDA.”

Back in November, The National Institute for Health and Care Excellence (NICE) gave an initial ‘no’ for Keytruda’s (pembrolizumab) use in treating bladder cancer through the English NHS.

NICE said that they could ‘‘not recommend pembrolizumbab’’ due to the incremental cost-effectiveness ratios (ICERs) being ‘‘higher than would normally be considered cost-effective for end-of-life treatments.’’

In America, the FDA cleared Keytruda in 2017 for certain patients with locally advanced or metastatic urothelial carcinoma in both the first and second-line settings. 

Conor Kavanagh

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