ABSTRACT

Description: Mylotarg is a 153-kDa immunotoxin consisting of a humanized monoclonal antibody (HP67.6) linked to a bacterial toxin, calicheamicin, with cytotoxic effect. The humanized antibody specifically binds the human CD33 antigen, which is expressed on normal and leukemic myeloid cells, and is produced in recombinant form in a modified murine NSO cell line. Mylotarg is presented as a lyophilized powder (5 mg/vial) to be resuspended before intravenous infusion.

Approval Date: 2000 (U.S.)