FDA Broadens Breyanzi’s Follicular Lymphoma Indication

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168096</fileName> <TBEID>0C05021B.SIG</TBEID> <TBUniqueIdentifier>MD_0C05021B</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240516T124507</QCDate> <firstPublished>20240516T130044</firstPublished> <LastPublished>20240516T130044</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240516T130044</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>M Alex Otto</byline> <bylineText>M. ALEXANDER OTTO, PA, MMS</bylineText> <bylineFull>M. ALEXANDER OTTO, PA, MMS</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <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 This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.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 (FDA) has granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics /Bristol Myers Squibb) for a</metaDescription> <articlePDF/> <teaserImage/> <teaser>For adults with relapsed/refractory follicular lymphoma, the FDA has approved an expanded indication for Breyanzi.</teaser> <title>FDA Broadens Breyanzi’s Follicular Lymphoma Indication</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">49434</term> <term>195</term> <term>233</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Broadens Breyanzi’s Follicular Lymphoma Indication</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription">The US Food and Drug Administration (FDA) has granted <span class="Hyperlink"><a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma?utm_medium=email&amp;utm_source=govdelivery">accelerated approval</a></span> to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics /Bristol Myers Squibb) for adults with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.</span> </p> <p>The approval broadens the use of the CAR T-cell therapy for follicular lymphoma. <span class="Hyperlink"><a href="https://www.fda.gov/media/145711/download?attachment">Previous approval</a></span> was limited to relapsed/refractory grade 3B disease. Lisocabtagene maraleucel also carries relapsed/refractory B-cell lymphoma and lymphocytic leukemia indications.<br/><br/>The new approval was based on the phase 2 single-arm TRANSCEND FL trial in 94 patients with relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.<br/><br/>Adequate bone marrow function and a performance score of 0-1 were required.<br/><br/>Patients received a single dose 2-7 days after completing lymphodepleting chemotherapy.<br/><br/>The overall response rate was 95.7%. The median duration of response was not reached after a median follow-up of 16.8 months.<br/><br/>The most common nonlaboratory adverse events, occurring in at least 20% of patients, were cytokine release syndrome, headache, musculoskeletal pain, fatigue, constipation, and fever.<br/><br/>Lisocabtagene maraleucel is available only through a Risk Evaluation and Mitigation Strategy program due to the risk for fatal cytokine release syndrome and neurologic toxicities.<br/><br/>A single treatment is almost a half million dollars, according to <span class="Hyperlink"><a href="http://drugs.com/">drugs.com</a></span>.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-broadens-breyanzis-follicular-lymphoma-indication-2024a10009c2">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>