gemtuzumab ozogamicin (Mylotarg)

following a full submission assessed under the end of life and orphan medicine process:

gemtuzumab ozogamicin (Mylotarg®) is accepted for restricted use within NHSScotland.

Indication under review: For combination therapy with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33 positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).

SMC restriction: use in patients with a favourable, intermediate or unknown cytogenetic profile.

In an open label, phase III study of adults with AML, the addition of gemtuzumab ozogamicin to standard intensive chemotherapy was associated with significant improvement in event free survival compared with standard intensive chemotherapy alone. Events included failure to achieve remission with induction therapy, relapse of disease, or death.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.