Quizartinib is recommended, within its marketing authorisation, as an option for newly diagnosed FLT3‑ITD‑positive acute myeloid leukaemia (AML) in adults, when used:
with standard cytarabine and anthracycline chemotherapy as induction treatment, then
with standard cytarabine chemotherapy as consolidation treatment, then
alone as maintenance treatment.
Quizartinib is only recommended if the company provides it according to the commercial arrangement.
Why the committee made this recommendation
Usual treatment for newly diagnosed FLT3‑ITD‑positive AML is midostaurin with chemotherapy as induction and consolidation treatment, then alone as maintenance treatment. After consolidation treatment, people may have a stem cell transplant.
Evidence from a clinical trial shows that quizartinib plus standard chemotherapy increases how long people live compared with placebo plus standard chemotherapy. Quizartinib has not been directly compared in a clinical trial with midostaurin. Results from indirect comparisons mostly suggest there is no difference in how long people having quizartinib live, or how likely it is that their AML will come back, compared with midostaurin. But these results are uncertain because:
the people in the midostaurin trial were younger than the people who would have quizartinib in the NHS, and clinical practice has changed since the trial was done
some important characteristics between people in the trials could not be compared.
Because of the uncertainties in the clinical evidence, the cost-effectiveness estimates are uncertain. But the most likely estimates are within the range that NICE considers an acceptable use of NHS resources. So, quizartinib is recommended.