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Nivolumab with platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric, gastro-oesophageal junction or oesophageal adenocarcinoma

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2 Information about nivolumab

Anticipated marketing authorisation indication

2.1 On 16 September 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a variation to the terms of the marketing authorisation for the medicinal product nivolumab (Opdivo, Bristol Myers Squibb). The CHMP adopted a new indication as follows: Nivolumab 'in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5'.

Dosage in the marketing authorisation

2.2 The dosage schedule for nivolumab will be available in the summary of product characteristics.

Price

2.3 The list price of nivolumab is £439 per 40 mg/4 ml concentrate for solution for infusion vial; £1,097 per 100 mg/10 ml concentrate for solution for infusion vial; and £2,633 per 240 mg/24 ml concentrate for solution for infusion vial (excluding VAT; BNF online, accessed August 2021).

2.4 The company has a commercial arrangement. This makes nivolumab available to the NHS with a discount and it would have also applied to this indication if the technology had been recommended. 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.