NICE Draft Guidance Rejects First-Line Yervoy for Advanced Melanoma

NICE Draft Guidance Rejects First-Line Yervoy for Advanced MelanomaEngland and Wales’ cost regulator, NICE, have published draft guidance recommending that Bristol-Myers Squibb’s Yervoy (ipilimumab) should only be used by the National Health Service (NHS) for patients in clinical trials, as current evidence is lacking.

The regulatory body has already approved the skin cancer drug as a second-line treatment for advanced malignant melanoma, but commented that the evidence provided by Bristol-Myers Squibb (B-MS) fails to decisively demonstrate the degree to which Yervoy can prolong life in previously untreated patients when compared to current standard care.

NICE’s chief executive, Sir Andrew Dillon, noted that NICE “understand that clinical trials are ongoing that could provide an answer to this important question, and are keen to see the recruitment and continued follow up of patients in these trials encouraged.”

Bristol-Myers Squibb has criticised the decision, arguing that, if upheld, it will restrict newly-diagnosed patients from gaining access to “one of the most significant treatment advances for this disease in many years” which has “the potential to significantly increase overall survival.”

Professor John Wagstaff, Consultant Oncologist at the South West Wales Cancer Institute & Swansea School of Medicine, commented that the skin cancer treatment “has demonstrated its ability to increase overall survival in this cancer, in some cases having a long-term effect on the survival of previously-treated patients,” so “making it available as a first treatment option should therefore be seen as an important step in helping to maximise survival in this disease.”

Newly-diagnosed skin cancer patients are also currently unable to access Yervoy through the national Cancer Drug Fund.


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