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NICE says OK to Keytruda for bladder cancer via the CDF

Becomes the first immunotherapy recommended for UC after chemotherapy


Certain bladder cancer patients in England will be able to get access to Merck Sharp and Dohme’s (MSD) blockbuster Keytruda (pembrolizumab) following a go-ahead from the UK’s cost-effectiveness watchdog.

The National Institute for Care and Health Excellence (NICE) has ruled that Keytruda can be made available as an option via the cancer drugs fund (CDF) for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy.

As per terms of the recommendation, the medication should be stopped at two years of uninterrupted treatment, or earlier in the event of disease progression.

Professor Thomas Powles, director of the Barts Cancer Centre, said the approval “opens a new chapter in the treatment of bladder cancer” and is a “bright ray of light for patients with this difficult disease”.

MSD’s KEYNOTE-045, the phase III study NICE based its decision on, showed Keytruda extended overall survival in patients by nearly three months more (10.3 months) than those on chemotherapy (7.4 months).

Powles, added: “Outcomes of patients with chemotherapy refractory metastatic bladder cancer remain stubbornly poor, [however] pembrolizumab is the first immune checkpoint inhibitor in this setting to show extended survival in this group of patients.”

According to Cancer Research UK, urothelial cancer is the most common form of bladder cancer and accounts for over 90% of cases and it is the only top ten cancer where the prognosis is getting worse.

Louise Houson, UK managing director for MSD, said: “MSD is really pleased that NICE has recommended pembrolizumab for eligible patients with advanced urothelial carcinoma, meaning it can now help bladder cancer patients in addition to those with non-small-cell lung cancer and melanoma.”

Meanwhile, the pharma giant could also see Keytruda close the gap with biggest-selling PD-1 inhibitor Opdivo for melanoma, but that remains to be seen.

Article by
Gemma Jones

16th March 2018

From: Regulatory



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