Favourable opinion for reimbursement in the indication “VANFLYTA (quizartinib) is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of VANFLYTA 17.7 mg and 26.5 mg (quizartinib) film-coated tablets is substantial in the MA indication.
Clinical Added Value
minor
Considering:
demonstration of the superiority of VANFLYTA (quizartinib) compared to placebo, administered in combination with standard chemotherapy during the induction and consolidation phases and as single-agent maintenance therapy, in terms of overall survival (HR = 0.776, CI95% = [0.615; 0.979]; p = 0.032),
and despite:
the absence of a demonstrated improvement in terms of event-free survival,
the absence of robust data enabling specific determination of the contribution of VANFLYTA (quizartinib) to the different treatment phases and, in particular, with respect to the effect of allogeneic HSCT,
the lack of robust data enabling differentiation between the contribution of VANFLYTA (quizartinib) in the maintenance phase in patients having received allogeneic HSCT and those who did not, in the absence of randomisation before the initiation of maintenance therapy,
a safety profile marked by the high frequency of early deaths (in the first 30 to 60 days), primarily related to an excess bone marrow toxicity following the addition of VANFLYTA (quizartinib) to intensive chemotherapy,
the exploratory nature of the quality of life data,
the impossibility of determining the role of VANFLYTA (quizartinib) compared to RYDAPT (midostaurine), given their concomitant development,
the Committee deems that VANFLYTA 17.7 mg and 26.5 mg (quizartinib) film-coated tablets, in combination with chemotherapies during the induction and consolidation phases and as single-agent maintenance therapy, provides a minor clinical added value (CAV IV), in the same way as RYDAPT (midostaurine), compared to induction and consolidation chemotherapies administered alone and without a maintenance phase.
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