Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration approved&nbsp;moxetumomab pasudotox-tdfk&nbsp;injection for the treatment of&nbsp;relapsed/refractory hairy cell leukemia (HCL)&nbsp;in adults&nbsp;who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.&nbsp;This&nbsp;CD22-directed cytotoxin is the first of this type of treatment for HCL.&nbsp;The&nbsp;approval&nbsp;was based on&nbsp;results from&nbsp;a&nbsp;single-arm, open-label clinical trial that included&nbsp;80 patients who had received prior treatment for HCL. Thirty percent of patients&nbsp;in the trial achieved durable complete response, and the overall response rate&nbsp;was 75 percent.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA approves new kind of treatment Lumoxiti (moxetumomab pasudotox-tdfk) for hairy cell leukemia <a href="https://t.co/ZCx82Z6qrG">https://t.co/ZCx82Z6qrG</a>
&mdash; Anthony M Crasto DR. (@amcrasto) <a href="https://twitter.com/amcrasto/status/1040522077835538432?ref_src=twsrc%5Etfw">September 14, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The most common adverse events associated with&nbsp;moxetumomab pasudotox-tdfk&nbsp;are&nbsp;infusion-related reactions&nbsp;(IRRs),&nbsp;edema, nausea, fatigue, headache,&nbsp;pyrexia, constipation, anemia,&nbsp;and diarrhea.&nbsp;The&nbsp;drug carries&nbsp;a Boxed Warning&nbsp;on&nbsp;the risk of developing capillary leak syndrome, symptoms of which include&nbsp;difficulty breathing, weight gain, hypotension, or swelling of arms, legs,&nbsp;and/or face. The Boxed Warning also notes the risk of hemolytic uremic syndrome.&nbsp;&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA Approves <a href="https://twitter.com/hashtag/Lumoxiti?src=hash&amp;ref_src=twsrc%5Etfw">#Lumoxiti</a> (moxetumomab pasudotox-tdfk) for Hairy Cell Leukemia <a href="https://twitter.com/hashtag/newdrugs?src=hash&amp;ref_src=twsrc%5Etfw">#newdrugs</a> &ndash; <a href="https://t.co/mWvowjMlDy">https://t.co/mWvowjMlDy</a>
&mdash; Drugs.com (@Drugscom) <a href="https://twitter.com/Drugscom/status/1040335059411197953?ref_src=twsrc%5Etfw">September 13, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Patients should be&nbsp;counseled on&nbsp;maintaining adequate fluid intake, and&nbsp;physicians should regularly monitor&nbsp;blood chemistry values.&nbsp;Other serious warnings include decreased renal function,&nbsp;IRRs,&nbsp;and electrolyte abnormalities.&nbsp;&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/lmaternal-hormonal-birth-control/">Is there a link between maternal hormonal birth control use and childhood leukemia?</a>&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/diabetes-associated-higher-cancer-risk/">Diabetes is associated with a higher cancer risk in women, but not men.</a>&nbsp;Source:&nbsp;<a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620448.htm">FDA</a>

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Latest News

FDA Approves Treatment for Relapsed/Refractory Hairy Cell Leukemia

Oncology

The U.S. Food and Drug Administration approved moxetumomab pasudotox-tdfk injection for the treatment of relapsed/refractory hairy cell leukemia (HCL) in adults who have ...

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