FDA Approves Epcoritamab for R/R Follicular Lymphoma

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168564</fileName> <TBEID>0C050CA2.SIG</TBEID> <TBUniqueIdentifier>MD_0C050CA2</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240627T124356</QCDate> <firstPublished>20240627T134523</firstPublished> <LastPublished>20240627T134523</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240627T134523</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>M. Alexander Otto, PA</byline> <bylineText>M. ALEXANDER OTTO, PA, MMS</bylineText> <bylineFull>M. ALEXANDER OTTO, PA, MMS</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The US Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US) for adults with relapsed or refractory follicular lymp</metaDescription> <articlePDF/> <teaserImage/> <teaser>The approval was based on the single-arm EPCORE NHL-1 trial in 127 patients who had received at least two lines of systemic therapy.</teaser> <title>FDA Approves Epcoritamab for R/R Follicular Lymphoma</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>hemn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">18</term> </publications> <sections> <term canonical="true">37225</term> <term>39313</term> </sections> <topics> <term canonical="true">233</term> <term>270</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Approves Epcoritamab for R/R Follicular Lymphoma</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription">The US Food and Drug Administration granted <span class="Hyperlink"><a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma?utm_medium=email&amp;utm_source=govdelivery">accelerated approval</a></span> to <span class="Hyperlink">epcoritamab</span>-bysp (Epkinly, Genmab US) for adults with relapsed or refractory <span class="Hyperlink">follicular lymphoma</span> after two or more lines of systemic therapy.</span> </p> <p>This marks the <span class="Hyperlink"><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf">second indication</a></span> for the bispecific CD20-directed CD3 T-cell engager. The agent was first approved in 2023 for relapsed or refractory diffuse large <span class="Hyperlink">B-cell lymphoma</span> in adults.<br/><br/>The current approval was based on the single-arm EPCORE NHL-1 trial in 127 patients with follicular lymphoma who had received at least two lines of systemic therapy.<br/><br/>After a two step-up dosing regimen, the overall response rate was 82%, with 60% of patients achieving a complete response. At a median follow-up of 14.8 months, the median duration of response was not reached. The 12-month duration of response was 68.4%.<br/><br/>Efficacy was similar in the 86 patients who received a three step-up dosing schedule.<br/><br/>Labeling carries a black box warning of <span class="Hyperlink">cytokine release syndrome</span> and immune effector cell–associated neurotoxicity syndrome. Adverse events in 20% or more of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, <span class="Hyperlink">diarrhea</span>, pyrexia, cough, and headache.<br/><br/>Decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin were the most common grade 3/4 laboratory abnormalities.<br/><br/>Three step-up dosing is the recommended regimen, with epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Dosing is increased by steps to the full 48 mg in cycle 1.<br/><br/>The price is $16,282.52 for 48 mg/0.8 mL, according to <span class="Hyperlink"><a href="https://www.drugs.com/price-guide/epkinly">drugs.com</a></span>.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-epcoritamab-r-r-follicular-lymphoma-2024a1000c07">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>