Pembrolizumab (Keytruda), for people with untreated metastatic colorectal cancer who have specific mutations in their cancer cells, has been approved by NICE today.
The draft guidance recommends pembrolizumab by MSD, known as Merck in the United States and Canada, for untreated metastatic colorectal cancer with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency.
High MSI or MMR deficiency occurs in roughly 4% of metastatic colorectal cancer patients. Around 450 people will be eligible for this treatment in England.
Colorectal cancer with high MSI or MMR deficiency is associated with a poorer prognosis and a greater risk of death than colorectal cancer that is microsatellite stable. There are currently no specific treatments for this type of colorectal cancer.
Clinical trial evidence shows that pembrolizumab increases the time before the cancer gets worse compared with current available treatments such as chemotherapy, and may also be more effective at extending life.
However, the independent appraisal committee found the long-term evidence is limited so it is uncertain how much overall survival benefit it offers.
Dr Kai-Keen Shiu, Consultant Medical Oncologist at UCLH NHS Foundation Trust said: “It is great news for our NHS that NICE have approved pembrolizumab as first line treatment for metastatic MSI-H/dMMR bowel cancer based on the results of this international trial.
“I am glad that we can now offer eligible patients a therapy which has been shown in the KEYNOTE-177 trial not only to be more effective in stopping tumours from growing versus chemotherapy, but is also shown to have more manageable side-effects. For some patients, access to this treatment could be truly life changing.”
Meindert Boysen, Deputy Chief Executive and Director of the Centre for Health Technology Evaluation at NICE, said: “There are currently no specific treatments for untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency.
“Pembrolizumab has shown the potential to extend the lives of hundreds of people with this form of colorectal cancer. It also works in a different way to current standard care with chemotherapy and the committee heard that people appreciated its faster and less frequent administration, and preferable adverse effects compared with chemotherapy. We are pleased, therefore, to be able to recommend pembrolizumab for routine use in the NHS.”
Pembrolizumab is given intravenously every three weeks. The average cost of a single administration is £5,260 at its list price but it will be available to the NHS at a discounted price through a confidential arrangement.
This is a syndicated feed from Pharmafile