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Gastroenterology 145 , 574582.e571 (2013)

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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)

[DOI] [PMC free article] [PubMed] [Google Scholar] Kaplan JR, Adams MR, Clarkson TB, Manuck SB, Shively CA, Williams JK

Role of GM-CSF in the inflammatory cytokine network that regulates neutrophil influx into the colonic mucosa during Clostridium difficile infection in mice

HR 0.73, 95%CI 0.63-0.84)