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FDA Approves Gilteritinib for FLT3+ AML

Jason M. Broderick @jasoncology
Published: Wednesday, Nov 28, 2018

The FDA has approved gilteritinib (Xospata) for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).

The CR rate was 11.6% (n = 16) and the CRh rate was 9.4% (n = 13). The median time to first response was 3.6 months (range, 0.9-9.6) among patients reaching CR/CRh.


During any 56-day post-baseline period, 33 (31.1%) of the 106 patients dependent on red blood cell (RBC) and/or platelet transfusions at baseline became independent of such transfusions. Seventeen (53.1%) of the remaining 32 patients who were RBC/platelet-transfusion independent at baseline remained independent of transfusion during any 56-day post-baseline period.

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