Gilteritinib [GILT2]

For the treatment of relapsed/refractory FLT3 mutation positive acute myeloid leukaemia in POST PUBESCENT CHILDREN where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with gilteritinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient is a post pubescent child.
3. The patient has a proven diagnosis of acute myeloid leukaemia.
4. The patient has a FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) as determined by a validated test.
5. The patient has relapsed/refractory FLT3 positive acute myeloid leukaemia.
6. The patient has not received previous systemic therapy with other FLT3 inhibitors (with the exception of sorafenib or midostaurin or quizartinib used in first-line therapy or in clinical trials in 1st line therapy).
7. The patient has a Lansky/Karnofsky performance score of 60 or above.
8. The use of gilteritinib will be as MONOTHERAPY and continued until disease progression or unacceptable toxicity or the time at which the patient is considered to be cured or until the patient receives a haematopoietic stem cell transplant whichever occurs first.
9. The prescribing clinician understands that patients whose disease responds to gilteritinib and who then go on to have a haematopoietic stem cell transplant cannot restart gilteritinib as maintenance therapy after the transplant. This is as a consequence of the optimised NICE recommendation.

Note

Note: patients who receive a stem cell transplant for FLT3 AML and who have not previously received treatment with gilteritinib cannot commence maintenance gilteritinib. Such patients can only receive gilteritinib if they relapse post- SCT.

10. Trust policy regarding unlicensed treatments has been followed as gilteritinib is not licensed in patients under the age of 18.
11. The use of gilteritinib has been discussed at a multi-disciplinary team (MDT) meeting which must include at least two consultants in the subspecialty with active and credible expertise in the relevant area, including at least one consultant paediatrician or a consultant with a Certificate of Completion of Training (CCT) which includes training in caring for children. The MDT should include a paediatric pharmacist and other professional groups appropriate to the disease area.
12. When a treatment break of more than 6 weeks beyond the expected cycle length is needed, I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment is recommenced.
13. Gilteritinib will be otherwise used as set out in its Summary of Product Characteristics (SmPC).

NHS funded From: 29 July 2026

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: In reference TA642 (12 August 2020)

Current Form Version

Note

The data on this page was produced using version 1.406 of the CDF list, downloaded from NHS England’s website on 12 August 2026 at 09:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.