2 Information about gemtuzumab ozogamicin

2 Information about gemtuzumab ozogamicin

Marketing authorisation indication

Gemtuzumab ozogamicin (Mylotarg, Pfizer) is indicated 'for the treatment of previously untreated, de novo CD33-positive acute myeloid leukaemia, except acute promyelocytic leukaemia for patients age 15 years and above, in combination with daunorubicin and cytarabine.'

Dosage in the marketing authorisation

The gemtuzumab ozogamicin dose is 3 mg/m2/dose (up to a maximum of 1×5-mg vial) infused over a 2-hour period.

Induction: gemtuzumab ozogamicin 3 mg/m2/dose (up to a maximum of 5 mg/dose) given on days 1, 4 and 7.

Consolidation courses 1 and 2: gemtuzumab ozogamicin 3 mg/m2/dose (up to a maximum of 5 mg/dose) given on day 1 of each course.

Price

£6,300 per 5-mg vial (excluding VAT; British national formulary [BNF] online [accessed August 2018]).

The company has a commercial arrangement. This makes gemtuzumab ozogamicin 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)