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Information on how to access Mylotarg™​​​​​​​​​​​​​​ (gemtuzumab ozogamicin) and cytarabine prescribing information and adverse event reporting can be found at the bottom of the page.


NICE approval

NICE Approved:

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

Statement from Scottish Medicines Consortium

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.

Explore More

Efficacy and Safety of MYLOTARG video

Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA study

Learn more

AML Landscape: Present and Future video

Watch Dr Eleni Tholouli discuss the NICE approval for MYLOTARG and efficacy data using the ALFA schedule

Learn more

AML, Acute Myeloid Leukaemia; NICE, National Institute for Health and Care Excellence; SMC, Scottish Medicines Consortium

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
  1. National Institute for Health and Care Excellence. Technology appraisal guidance (TA545): Gemtuzumab ozogamicin for untreated acute myeloid leukaemia (Published: 14 November 2018). Available at: Accessed March 2021.
  2. Scottish Medicines Consortium. Gemtuzumab ozogamicin (MYLOTARG): SMC2089 (Published: 08 October 2020). Available at:[accessed March 2020]. Accessed: March 2021.
  3. MYLOTARG™ Summary of Marketing Product Characteristics.
PP-MYL-GBR-0235. March 2021

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