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With regard to the substantial clinical improvement criterion, the applicant asserted that VANFLYTA represents a substantial clinical improvement for Medicare beneficiaries and offers a treatment option for newly diagnosed patients with FLT3-ITD+ AML, the most treatment-resistant AML subtype, and patients receiving VANFLYTA plus standard induction and consolidation therapy, and then continuation monotherapy for up to three years, had significantly reduced rates of relapse and overall improved survival, regardless of whether they received a hematopoietic stem cell transplantation (HSCT) when compared to the placebo group

10.1093/jnci/92.12.977 50 WeisbordS

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