2 Information about inotuzumab ozogamicin

2 Information about inotuzumab ozogamicin

Marketing authorisation

Inotuzumab ozogamicin (Besponsa, Pfizer) is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia-chromosome-positive relapsed or refractory B-cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor.

Dosage in the marketing authorisation

Intravenously at a starting dose of 1.8 mg/m2 per cycle (0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15), in 3- to 4-week cycles. Cycle 1 lasts for 3 weeks, and each subsequent cycle lasts for 4 weeks. See the summary of product characteristics for further details.

Price

£8,048 per 1 mg vial of powder concentrate for solution for infusion (excluding VAT; BNF 2018). The company has a commercial arrangement. This makes inotuzumab 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)