NICE approves gilteritinib for treating relapsed or refractory acute myeloid leukaemia

The National Institute of Health and Care Excellence (NICE) have today made an announcement for the recommendation of gilteritinib as an option in adults with relapsed or refractory FLT3-positive acute myeloid leukaemia (AML).

The National Institute of Health and Care Excellence (NICE) have today made an announcement for the recommendation of gilteritinib as an option in adults with relapsed or refractory FLT3-positive acute myeloid leukaemia (AML).

The brand name for this treatment is Xospata© and it is produced by Astellas Pharma.

How does gilteritinib work?

Mutations in the FLT3 gene represent the most common type of mutation that is present in AML patients, affecting up to 30% of patients. Patients with FLT3 mutations typically have poorer prognosis, meaning they respond less well or are more likely to relapse after the standard treatments. Gilteritinib is a type of targeted therapy. It is a FLT3 inhibitor and it works by binding to the FLT3 protein and blocking its activity. FLT3 is a tyrosine kinase receptor, a type of protein that is involved in many pathways promoting the growth and survival of leukaemia cells.    

Why has NICE made these recommendations?

FLT3 mutation is associated with a higher risk of relapse and an overall poor prognosis in AML patients with this mutation. In a patient where the first course of chemotherapy has not worked, or where a patient has relapsed, then salvage chemotherapy is offered. The clinical evidence for this NICE recommendation came from the ADMIRAL trial, which compared gilteritinib with salvage chemotherapy. The study showed a significant improvement in overall survival in patients treated with giltertinib (average survival of 9 months) compared with those treated with salvage chemotherapy (average survival of 5.5 months).

There are very few treatment options currently available for patients with relapsed or refractory AML with a FLT3 mutation. The current salvage chemotherapy offered comes with side effects which impact the patient’s quality of life, in addition to not being very effective. Gilteritinib is an oral tablet, which means the treatment can be administered at home, which some patients might prefer, especially towards the end of their life.

You can find more information and the relevant documents on the NICE website here.

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