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With respect to the substantial similarity criteria, the applicant asserted that VANFLYTA is not substantially similar to other currently available technologies because VANFLYTA is the first drug to be expressly developed ( as a FLT3 inhibitor, not a multi-kinase inhibitor, and specifically optimized to inhibit the FLT3-ITD AML, thereby targeting the subpopulation of newly diagnosed patients with the worst prognosis (higher risk of relapse and worse overall survival)

HR 0.73, 95%CI 0.63-0.84)