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A supplemental new drug application has been approved by the FDA&nbsp;to update the label for gilteritinib (Xospata) to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory <em>FLT3</em>-mutant AML.

In an 8-3 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee has recommended against approving a new drug application for quizartinib for adult patients with relapsed/refractory&nbsp;FLT3-ITD&ndash;positive acute myeloid leukemia. The FDA is now scheduled to make a final decision on the application by&nbsp;August 25, 2019.