Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration&nbsp;(FDA)&nbsp;approved&nbsp;gilteritinib&nbsp;to treat&nbsp;adults&nbsp;with&nbsp;relapsed/refractory acute myeloid leukemia (AML) with&nbsp;FLT3&nbsp;mutation, as detected by the&nbsp;FDA-approved&nbsp;LeukoStrat&nbsp;CDx&nbsp;FLT3 Mutation Assay.&nbsp;&nbsp;The decision was based on results&nbsp;from&nbsp;the randomized, phase III&nbsp;ADMIRAL study&nbsp;that included&nbsp;138 patients with relapsed/refractory&nbsp;FLT3-positive&nbsp;AML.&nbsp;Patients&nbsp;received oral&nbsp;gilteritinib&nbsp;120 mg daily, and&nbsp;21%&nbsp;achieved complete remission&nbsp;(CR)&nbsp;or&nbsp;CR&nbsp;with partial hematologic recovery.&nbsp;A total of&nbsp;106 patients required red blood cell or platelet transfusions at the start of treatment,&nbsp;and&nbsp;31%&nbsp;became transfusion-free for at least 56 days&nbsp;following treatment with gilteritinib.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
We&rsquo;ve learned from past failures Erkut Bajceci <a href="https://twitter.com/AstellasCA?ref_src=twsrc%5Etfw">@AstellasCA</a> said of yesterday&rsquo;s achievement of gaining <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> approval for the company&rsquo;s FLT3 inhibitor gilteritinib for AML <a href="https://twitter.com/hashtag/ASH18?src=hash&amp;ref_src=twsrc%5Etfw">#ASH18</a> <a href="https://twitter.com/hashtag/llsroundtable?src=hash&amp;ref_src=twsrc%5Etfw">#llsroundtable</a> <a href="https://t.co/kzgAFf0rDj">pic.twitter.com/kzgAFf0rDj</a>
&mdash; The Leukemia &amp; Lymphoma Society (@LLSusa) <a href="https://twitter.com/LLSusa/status/1068334251215474688?ref_src=twsrc%5Etfw">November 30, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The most common adverse events associated with gilteritinib&nbsp;were myalgia/arthralgia,&nbsp;fatigue, and&nbsp;liver transaminase.&nbsp;Physicians should&nbsp;monitor patients for posterior reversible encephalopathy syndrome, prolonged QT interval,&nbsp;and pancreatitis.&nbsp;In rare cases,&nbsp;differentiation syndrome&nbsp;was observed in patients taking gilteritinib. Women who are pregnant or breastfeeding should&nbsp;not take gilteritinib.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA stamps fast OK on Astellas' pioneering FLT3 AML drug gilteritinib, expanding on a record year for new appr &hellip; &ndash; <a href="https://t.co/YjKkV1FHgn">https://t.co/YjKkV1FHgn</a>
&mdash; Chris Burns (@ausmedchemist) <a href="https://twitter.com/ausmedchemist/status/1068307876752457728?ref_src=twsrc%5Etfw">November 30, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The ADMIRAL study is ongoing, and survival data are expected in 2019.&nbsp;&nbsp;In an earlier study of gilteritinib, the first-in-human phase I/II&nbsp;CHRYSALIS&nbsp;trial&nbsp;found that&nbsp;49% of patients with&nbsp;relapsed/refractory&nbsp;FLT3-positive&nbsp;AML responded to&nbsp;treatment. The median survival was more than 7 months.&nbsp;Conversely, just&nbsp;12% of patients without&nbsp;FLT3&nbsp;mutations responded to gilteritinib.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA Approves <a href="https://twitter.com/hashtag/Gilteritinib?src=hash&amp;ref_src=twsrc%5Etfw">#Gilteritinib</a> for <a href="https://twitter.com/hashtag/FLT3?src=hash&amp;ref_src=twsrc%5Etfw">#FLT3</a>+ AML &#8294;<a href="https://twitter.com/OncLive?ref_src=twsrc%5Etfw">@OncLive</a>&#8297; | <a href="https://twitter.com/hashtag/leusm?src=hash&amp;ref_src=twsrc%5Etfw">#leusm</a> <a href="https://twitter.com/hashtag/bmtsm?src=hash&amp;ref_src=twsrc%5Etfw">#bmtsm</a> <a href="https://t.co/7hz6f3YUtW">https://t.co/7hz6f3YUtW</a>
&mdash; Naveen Pemmaraju, MD (@doctorpemm) <a href="https://twitter.com/doctorpemm/status/1067976991364866054?ref_src=twsrc%5Etfw">November 29, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><a href="https://proddocwire.wpengine.com/docwire-pick/fda-approves-acute-myeloid-leukemia/">FDA approves a new treatment for patients with AML who cannot undergo intensive chemotherapy.</a>&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/fda-approves-treatment-cancers/">FDA approves a treatment for cancers with NTRK gene.</a>&nbsp;Source:&nbsp;<a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627072.htm">FDA</a>

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FDA Approves Treatment for FLT3-Mutated AML

Oncology

The U.S. Food and Drug Administration (FDA) approved gilteritinib to treat adults with relapsed/refractory acute myeloid leukemia (AML) with FLT3 mutation, as ...

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