2 Information about dinutuximab beta

2 Information about dinutuximab beta

Marketing authorisation indication

Dinutuximab beta (Qarziba, EUSA Pharma) has a marketing authorisation 'for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.

In patients with a history of relapsed or refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2).'

The marketing authorisation was granted under 'exceptional circumstances'. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the drug for which authorisation is being sought, because of the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Dosage in the marketing authorisation

There are 2 modes of administration:

  • continuous intravenous infusion over the first 10 days of each course at a daily dose of 10 mg/m2 or

  • 5 daily infusions of 20 mg/m2 administered over 8 hours, on the first 5 days of each course.

When IL-2 is combined with dinutuximab beta, it should be administered as subcutaneous injections of 6×106 IU/m2/day, for 2 periods of 5 consecutive days, resulting in an overall dose of 60×106 IU/m2 per course. The first 5-day course should start 7 days before the first infusion of dinutuximab beta and the second 5-day course should start at the same time as dinutuximab beta infusion (days 1 to 5 of each dinutuximab beta course).

The individual dose is determined based on the body surface area and should be a total of 100 mg/m2 per course.

Based on the severity of adverse drug reactions to dinutuximab beta, patients may have a dose reduction of 50% or a temporary interruption of the infusion. As a result, either the infusion period is prolonged or, if tolerated, the infusion rate may be increased up to 3 ml/hour (continuous infusion), in order to administer the total dose.

Price

The dinutuximab beta list price is £7,610 per vial (excluding VAT; company submission).

The average cost of a course of treatment (body surface area of 0.63 m2 and age 3) is £152,200.

The company has a commercial arrangement. This makes dinutuximab beta 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)