Speedy approval for melanoma drug combination

17 June 2016

Two immunotherapy drugs, nivolumab and ipilimumab are approved for NHS use by NICE for the treatment of advanced melanoma despite the potential side-effects.

Melanoma is the sixth most common cancer in the UK; late stage melanoma has an average five-year survival rate of 15%-20%. Immunotherapy - getting the body to recognise cancer as an invader and fight it -  is one of the most promising fields of ongoing cancer research. The new drugs, both produced by Bristol-Myers-Squibb (BMY) have both shown promise as monotherapies, but early data from a clinical study using the two together recorded an 18-month survival rate of 69%, almost double that of ipilimumab alone.

The two drugs work to suppress the ability of cancer cells ‘handshaking’ with the immune systems T-cells. Nivolumab blocks the PD-1 receptor in immune cells, receptors which cancer cells can u se to mask their presence. Ipilimumab binds to the CTLA-4 molecule key to regulating immune responses. 

NICE have moved quickly to approve the combined therapy, a speedy result which has been helped by BMY agreeing to provide a discount to the NHS, bringing the cost of the therapy under NICE’s cost-effectiveness ceiling of £30,000 per year of quality life gained.

The two drugs have an extensive list of side-effects but NICE concluded that those effects, whilst severe did not outweigh the positives, but the toxicity of the treatment meant it was a "promising new advance" only for those patients strong enough to withstand the side-effects.

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