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FDA Grants Gilteritinib Fast Track Designation for AML

Jason Harris
Published: Wednesday, Oct 11, 2017

Steven Benner, MD

Steven Benner, MD
The FDA has granted Fast Track designation to gilteritinib for adult patients with FLT3 mutation-positive relapsed/refractory acute myeloid leukemia (AML), according to Tokyo-based Astellas Pharma.

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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