Midostaurin [MID3]

For treating newly diagnosed FLT3 mutation positive acute myeloid leukaemia (FLT3-ITD or FLT3-TKD) in POST PUBESCENT CHILDREN LESS THAN 18 YEARS OLD where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with midostaurin will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. This patient is a post pubescent child less than 18 years old and has a confirmed diagnosis of acute myeloid leukaemia. Note: midostaurin is not licensed for AML in this age group and hence completion of this form also confirms that Trust policy is being followed as regards the use of unlicensed medicines. Note: For adults there is a separate blueteq form.
  3. The patient’s AML has a FLT3 mutation (ITD or TKD) as determined by a validated test. Please mark below which type of FLT3 mutation applies to this patient:
  • ITD disease or
  • TKD disease
  1. The patient is newly diagnosed with FLT3 positive acute myeloid leukaemia and either has not received any induction chemotherapy or has only received a single cycle of induction chemotherapy whilst awaiting FLT3 status. Please record the status as to induction chemotherapy:
  • the patient has not yet received any induction chemotherapy or
  • the patient has received only a single cycle of induction chemotherapy whilst awaiting the FLT3 result
  1. The patient is fit for intensive induction chemotherapy.
  2. The patient will be treated with midostaurin only in combination with standard mitoxantrone and cytarabine induction chemotherapy and then in combination with high dose cytarabine consolidation chemotherapy unless this patient is eligible for and has been entered into the NCRI Optimise-FLT3 Trial (ISRCTN 34016918) in which case midostaurin can also be given in combination with gemtuzumab ozogamicin with either DA or FLAG-Ida induction chemotherapy according to the Optimise-FLT3 trial protocol. Note: Midostaurin is excluded from the NHS England Treatment Breaks Policy.
  3. As maintenance monotherapy, midostaurin is to be only used in patients in complete remission of their AML.
  4. In the maintenance monotherapy phase, a maximum of 12 x 28-day cycles of midostaurin will be used.
  5. If the patient proceeds to a stem cell transplant, midostaurin will be permanently discontinued prior to the stem cell transplant conditioning regimen.
  6. Midostaurin is to be otherwise used as set out in its Summary of Product Characteristics.

[NHS funded]{.badge .rounded-pill .bg-success} From: 03 February 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA523 (13 June 2018)

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