MYLOTARG (gemtuzumab ozogamicin),  with daunorubicin (DNR) and cytarabine (AraC), is recommended as an option for untreated de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL), in people 15 years and over, only if:

1. they start induction therapy when either the cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (that is, because the test was unsuccessful) or when their cytogenetic test results are not yet available and
2. they start consolidation therapy when their cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (because the test was unsuccessful) and
   
3. the company provides MYLOTARG according to the commercial agreement
   

Following a full submission assessed under the end of life and orphan medicine process²:

Gemtuzumab ozogamicin (Mylotarg) is accepted for restricted use within NHS Scotland.

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.