2 The technology

2 The technology

Description of the technology

Nivolumab (Opdivo, Bristol–Myers Squibb) is a human monoclonal antibody that blocks an immune checkpoint protein receptor called programmed cell death protein 1 (PD‑1) to promote an anti-tumour response.

Marketing authorisation

Nivolumab 'as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults'.

Before the marketing authorisation was granted (April 2016), nivolumab was available in the NHS through the early access to medicines scheme.

Adverse reactions

The most common adverse reactions with nivolumab in clinical trials were tiredness, rash, pruritus, diarrhoea, nausea and decreased appetite (occurring in more than 10% of people). For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

3 mg/kg given intravenously every 2 weeks.

Price

The list price is £439 per 40‑mg vial or £1,097 per 100‑mg vial.

The company has a commercial arrangement. This makes nivolumab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)