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The agent had already been approved for several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer as well as adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.
The current accelerated approval is the first tumor-agnostic approval of a HER2-directed therapy and antibody drug conjugate.
“Until approval of trastuzumab deruxtecan, patients with metastatic HER2-positive tumors have had limited treatment options,” Funda Meric-Bernstam, MD, chair of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, Houston, said in an AstraZeneca press statement. “Based on the clinically meaningful response rates across clinical trials, this tumor-agnostic approval means that patients may now be treated with a HER2-directed medicine.”
Approval was based on findings in 192 patients enrolled in either the DESTINY-PanTumor02 trial, the DESTINY-Lung01 trial, or the DESTINY-CRC02 trial. Patients in the multicenter trials underwent treatment until disease progression, death, withdrawal of consent or unacceptable toxicity.
Confirmed objective response rates were 51.4%, 52.9%, and 46.9% in the three studies, respectively. Median duration of response was 19.4, 6.9, and 5.5 months, respectively.
The most common adverse reactions occurring in at least 20% of patients included decreased white blood cell count, hemoglobin, lymphocyte count, and neutrophil count, as well as nausea, fatigue, platelet count, vomiting, alopecia, diarrhea, stomatitis, and upper respiratory tract infection.
Full prescribing information includes a boxed warning about the risk for interstitial lung disease and embryo-fetal toxicity.
The recommended dosage is 5.4 mg/kg given as an intravenous infusion one every 3 weeks until disease progression or unacceptable toxicity.
A version of this article appeared on Medscape.com.
The agent had already been approved for several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer as well as adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.
The current accelerated approval is the first tumor-agnostic approval of a HER2-directed therapy and antibody drug conjugate.
“Until approval of trastuzumab deruxtecan, patients with metastatic HER2-positive tumors have had limited treatment options,” Funda Meric-Bernstam, MD, chair of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, Houston, said in an AstraZeneca press statement. “Based on the clinically meaningful response rates across clinical trials, this tumor-agnostic approval means that patients may now be treated with a HER2-directed medicine.”
Approval was based on findings in 192 patients enrolled in either the DESTINY-PanTumor02 trial, the DESTINY-Lung01 trial, or the DESTINY-CRC02 trial. Patients in the multicenter trials underwent treatment until disease progression, death, withdrawal of consent or unacceptable toxicity.
Confirmed objective response rates were 51.4%, 52.9%, and 46.9% in the three studies, respectively. Median duration of response was 19.4, 6.9, and 5.5 months, respectively.
The most common adverse reactions occurring in at least 20% of patients included decreased white blood cell count, hemoglobin, lymphocyte count, and neutrophil count, as well as nausea, fatigue, platelet count, vomiting, alopecia, diarrhea, stomatitis, and upper respiratory tract infection.
Full prescribing information includes a boxed warning about the risk for interstitial lung disease and embryo-fetal toxicity.
The recommended dosage is 5.4 mg/kg given as an intravenous infusion one every 3 weeks until disease progression or unacceptable toxicity.
A version of this article appeared on Medscape.com.
The agent had already been approved for several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer as well as adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.
The current accelerated approval is the first tumor-agnostic approval of a HER2-directed therapy and antibody drug conjugate.
“Until approval of trastuzumab deruxtecan, patients with metastatic HER2-positive tumors have had limited treatment options,” Funda Meric-Bernstam, MD, chair of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, Houston, said in an AstraZeneca press statement. “Based on the clinically meaningful response rates across clinical trials, this tumor-agnostic approval means that patients may now be treated with a HER2-directed medicine.”
Approval was based on findings in 192 patients enrolled in either the DESTINY-PanTumor02 trial, the DESTINY-Lung01 trial, or the DESTINY-CRC02 trial. Patients in the multicenter trials underwent treatment until disease progression, death, withdrawal of consent or unacceptable toxicity.
Confirmed objective response rates were 51.4%, 52.9%, and 46.9% in the three studies, respectively. Median duration of response was 19.4, 6.9, and 5.5 months, respectively.
The most common adverse reactions occurring in at least 20% of patients included decreased white blood cell count, hemoglobin, lymphocyte count, and neutrophil count, as well as nausea, fatigue, platelet count, vomiting, alopecia, diarrhea, stomatitis, and upper respiratory tract infection.
Full prescribing information includes a boxed warning about the risk for interstitial lung disease and embryo-fetal toxicity.
The recommended dosage is 5.4 mg/kg given as an intravenous infusion one every 3 weeks until disease progression or unacceptable toxicity.
A version of this article appeared on Medscape.com.
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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167620</fileName> <TBEID>0C04F79B.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F79B</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240409T102814</QCDate> <firstPublished>20240409T103534</firstPublished> <LastPublished>20240409T103534</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240409T103534</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Sharon Worcester</byline> <bylineText>SHARON WORCESTER, MA</bylineText> <bylineFull>SHARON WORCESTER, MA</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 (FDA) has expanded the approval of fam-trastuzumab–deruxtecan-nxki (Enhertu; AstraZeneca and Daiichi Sankyo, Inc) to adults </metaDescription> <articlePDF/> <teaserImage/> <title>FDA Expands Enhertu Indication to HER2-Positive Solid Tumors</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> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term canonical="true">31</term> <term>23</term> </publications> <sections> <term>27980</term> <term>39313</term> <term canonical="true">27979</term> <term>37225</term> </sections> <topics> <term canonical="true">192</term> <term>270</term> <term>278</term> <term>67020</term> <term>39570</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Expands Enhertu Indication to HER2-Positive Solid Tumors</title> <deck/> </itemMeta> <itemContent> <p><br/><br/><span class="tag metaDescription">The US Food and Drug Administration (FDA) has expanded the approval of fam-trastuzumab–deruxtecan-nxki (Enhertu; AstraZeneca and Daiichi Sankyo, Inc) to adults with unresectable or metastatic <span class="Hyperlink">HER2-</span>positive solid tumors who have no satisfactory alternative after prior systemic treatment.</span><br/><br/>The agent had already been approved for several cancer types, including certain patients with unresectable or metastatic HER2-positive <span class="Hyperlink">breast cancer</span> as well as adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.<br/><br/>The current <span class="Hyperlink"><a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2">accelerated approval</a></span> is the first tumor-agnostic approval of a HER2-directed therapy and antibody drug conjugate.<br/><br/>“Until approval of <span class="Hyperlink">trastuzumab deruxtecan</span>, patients with metastatic HER2-positive tumors have had limited treatment options,” Funda Meric-Bernstam, MD, chair of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, Houston, said in an AstraZeneca <span class="Hyperlink">press statement</span>. “Based on the clinically meaningful response rates across clinical trials, this tumor-agnostic approval means that patients may now be treated with a HER2-directed medicine.”<br/><br/>Approval was based on findings in 192 patients enrolled in either the <span class="Hyperlink"><a href="https://classic.clinicaltrials.gov/ct2/show/NCT04482309">DESTINY-PanTumor02</a></span> trial, the <span class="Hyperlink"><a href="https://classic.clinicaltrials.gov/ct2/show/NCT03505710">DESTINY-Lung01</a></span> trial, or the <span class="Hyperlink"><a href="https://classic.clinicaltrials.gov/ct2/show/NCT03505710">DESTINY-CRC02</a></span> trial. Patients in the multicenter trials underwent treatment until disease progression, death, withdrawal of consent or unacceptable toxicity.<br/><br/>Confirmed objective response rates were 51.4%, 52.9%, and 46.9% in the three studies, respectively. Median duration of response was 19.4, 6.9, and 5.5 months, respectively.<br/><br/>The most common adverse reactions occurring in at least 20% of patients included decreased white blood cell count, hemoglobin, lymphocyte count, and neutrophil count, as well as nausea, fatigue, platelet count, vomiting, alopecia, <span class="Hyperlink">diarrhea</span>, stomatitis, and <span class="Hyperlink">upper respiratory tract infection</span>.<br/><br/>Full <span class="Hyperlink"><a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">prescribing information</a></span> includes a boxed warning about the risk for interstitial lung disease and embryo-fetal toxicity. <br/><br/>The <span class="Hyperlink"><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761139s000lbl.pdf">recommended dosage</a></span> is 5.4 mg/kg given as an intravenous infusion one every 3 weeks until disease progression or unacceptable toxicity.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-expands-enhertu-indication-her2-positive-solid-tumors-2024a10006ns?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p>The agent had already been approved for several cancer types.</p> </itemContent> </newsItem> </itemSet></root>