2 Information about daratumumab

2 Information about daratumumab

Description of the technology

Daratumumab (Darzalex, Janssen) is a humanised monoclonal antibody that targets the CD38 protein, thereby killing multiple myeloma cells. It is given intravenously.

Marketing authorisation indication

Daratumumab has a marketing authorisation in the UK for treating adults with 'relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy'.

Adverse reactions

The most common adverse reactions are infusion-related reactions including throat irritation, dyspnoea, nausea and cough. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Dosage in the marketing authorisation

The recommended dose of daratumumab is 16 mg/kg body weight given by intravenous infusion weekly from weeks 1 to 8, every 2 weeks from weeks 9 to 24, and every 4 weeks from week 25 onwards until disease progression.

Price

The list price for daratumumab is £360.00 for the 100-mg vial and £1,440.00 for the 400-mg vial (excluding VAT). Assuming an average body weight of 73.91 kg, and an average treatment duration of 3.4 months, the cost of a course of treatment is £68,862 excluding administration costs, and £74,531 including administration costs.

The company had agreed a patient access scheme with the Department of Health. However, the managed access agreement agreed between the company and NHS England has replaced this patient access scheme.

  • National Institute for Health and Care Excellence (NICE)