FDA Expands Durvalumab Label to Endometrial Cancer

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168441</fileName> <TBEID>0C050999.SIG</TBEID> <TBUniqueIdentifier>MD_0C050999</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240617T171050</QCDate> <firstPublished>20240618T093316</firstPublished> <LastPublished>20240618T093316</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240618T093316</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 This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.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 has expanded the indication for durvalumab (Imfinzi, AstraZeneca) to include mismatch repair deficient (dMMR) newly diagnose</metaDescription> <articlePDF/> <teaserImage/> <teaser>Approval of the new indication was based on the phase 3 DUO-E trial, which included women with newly diagnosed advanced or recurrent dMMR endometrial cancer. </teaser> <title>FDA Expands Durvalumab Label to Endometrial Cancer</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>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">31</term> <term>23</term> </publications> <sections> <term>37225</term> <term>39313</term> <term>27980</term> <term canonical="true">27979</term> </sections> <topics> <term canonical="true">217</term> <term>270</term> <term>38029</term> <term>218</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Expands Durvalumab Label to Endometrial Cancer</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription">The US Food and Drug Administration has <span class="Hyperlink"><a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-chemotherapy-mismatch-repair-deficient-primary-advanced-or-recurrent?utm_medium=email&amp;utm_source=govdelivery">expanded</a></span> the indication for <span class="Hyperlink"><a href="https://reference.medscape.com/drug/imfinzi-durvalumab-1000145">durvalumab</a></span> (Imfinzi, AstraZeneca) to include mismatch repair deficient (dMMR) newly diagnosed advanced or recurrent <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/254083-overview">endometrial cancer</a></span> in combination with <span class="Hyperlink"><a href="https://reference.medscape.com/drug/paraplatin-carboplatin-342107">carboplatin</a></span> and paclitaxel followed by single-agent use for maintenance.</span> </p> <p>Originally approved in 2017, the programmed death ligand 1 inhibitor caries <span class="Hyperlink"><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s048lbl.pdf">previously approved indications</a></span> for non–small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma.<br/><br/>Approval of the new indication was based on the phase 3 DUO-E trial, which included 95 women with newly diagnosed advanced or recurrent dMMR endometrial cancer. Patients were randomized to durvalumab 1120 mg or placebo with carboplatin plus paclitaxel every 3 weeks for a maximum of six cycles followed by durvalumab 1500 mg every 4 weeks until disease progression.<br/><br/>Median progression-free survival (PFS) was 7 months in the placebo arm but not reached in the durvalumab group. Overall survival outcomes were immature at the PFS analysis.<br/><br/>A quarter or more of durvalumab patients experienced peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/184704-overview">constipation</a></span>, rash, <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/928598-overview">diarrhea</a></span>, vomiting, and cough.<br/><br/>The recommended treatment regimen for dMMR endometrial cancer in women who weigh ≥ 30 kg is 1120 mg with carboplatin plus paclitaxel every 3 weeks for six cycles, followed by single-agent durvalumab 1500 mg every 4 weeks.<br/><br/>The price of 2.4 mL of durvalumab at a concentration of 50 mg/mL is $1027, according to <span class="Hyperlink"><a href="https://www.drugs.com/price-guide/imfinzi">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-expands-durvalumab-label-endometrial-cancer-2024a1000b7m">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>