2 The technology

2.1 Nivolumab (Opdivo, Bristol‑Myers Squibb) is a human monoclonal antibody (immunoglobulin G4) that blocks the programmed cell death‑1 receptor (PD‑1). This receptor is part of the immune checkpoint pathway, and blocking its activity may promote an anti-tumour immune response. Nivolumab has a marketing authorisation as monotherapy 'for treating advanced (unresectable or metastatic) melanoma in adults'. It is administered intravenously over 60 minutes at a dose of 3 mg/kg every 2 weeks. The summary of product characteristics recommends that 'treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated'.

2.2 The most common (occurring in 15% or more of people) adverse reactions with nivolumab in clinical trials of advanced melanoma were fatigue, rash, itching, diarrhoea, and nausea. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.3 The acquisition cost of nivolumab is £439 per 4 ml (40 mg) vial and £1097 per 10 ml (100 mg) vial (excluding VAT; company's submission). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)