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FDA Approval Sought for Gilteritinib in FLT3+ AML

Published: Tuesday, Apr 24, 2018

blood cellsA new drug application (NDA) has been filed with the FDA for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML), according to Astellas Pharma, the manufacturer of the FLT3 inhibitor.

Exposure-related inhibition of FLT3 phosphorylation increased along with increasing gilteritinib concentrations in plasma. Most patients receiving a daily dose of 80 mg or higher had at least 90% of FLT3 phosphorylation inhibition by day 8. In-vivo inhibition of FLT3 occurred at all dose levels.
Perl AE, Altman JK, Cortes J, et al. Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1–2 study. Lancet Oncol. 2017;18:1061-1075.

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