NICE ‘yes’ for Opdivo offers patients with advanced skin cancer new treatment option
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NHS patients in England and Wales will be able to access an innovative treatment option that offers a potentially rapid and durable response in patients with previously untreated advanced melanoma, compared with chemotherapy.
Bristol-Myers Squibb (BMS) has announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) which recommends Opdivo (nivolumab), as monotherapy, for the treatment of advanced (unresectable or metastatic) melanoma in adult patients. This guidance means that NHS patients in England and Wales will be able to access an innovative treatment option that offers a potentially rapid and durable response in patients with previously untreated advanced melanoma, compared with chemotherapy. Melanoma is the most dangerous form of skin cancer. In 2012 around 13,500 people were diagnosed in the UK and approximately 2,100 people died from the disease.
Commenting on the decision, Professor John Wagstaff, Consultant Oncologist at the South West Wales Cancer Institute & Swansea College of Medicine, said: “Today’s decision is very welcome news for patients with advanced melanoma as there are limited treatment options that have been shown to extend survival in this devastating disease. Nivolumab has an innovative mode of action which will be a vital addition to our treatment armamentarium.”
Cancer cells in tumours can exploit immune checkpoint pathways, allowing them to hide from the immune system and be shielded from immune attack. Nivolumab is a PD-1 (programmed death-1) immune checkpoint inhibitor[vi] that works by harnessing the ability of the immune system to find and fight cancer.
“Melanoma can progress very quickly and many patients simply can’t afford to wait for treatment”, said Gill Nuttall, Founder, Melanoma UK. “We are therefore really pleased that NICE has now committed to making this medicine available to NHS patients. Immunotherapies are changing survival expectations in cancer and we need to do more to bring patient access to these potentially life-extending cancer medicines as quickly as possible.”
Melanoma is the most dangerous form of skin cancer and can be fatal if it has advanced to a stage where it cannot be surgically removed because it has spread to other parts of the body.
“We welcome today’s decision from NICE, which is positive news for melanoma patients in the UK,” said Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland. “However, we are mindful that lung cancer patients continue to await a final decision on this medicine. Recently, NICE issued draft guidance, which does not recommend nivolumab in advanced lung cancer. Its final guidance for these patients will be issued in May 2016. We hope that this can be revisited and are committed to continued collaboration with the reimbursement authorities to ensure that UK lung cancer patients gain rapid access to our innovative medicines in the same way that melanoma patients now will.”
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