{"id":8022,"date":"2026-01-07T12:53:16","date_gmt":"2026-01-07T20:53:16","guid":{"rendered":"https:\/\/metastatictrialtalk.org\/?p=7838"},"modified":"2026-01-07T12:53:16","modified_gmt":"2026-01-07T20:53:16","slug":"enhertu-2","status":"publish","type":"post","link":"https:\/\/breastcancertrialtalk.org\/?p=8022","title":{"rendered":"FDA Expands Approval for Enhertu\u00ae"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-6818 size-medium alignleft\" src=\"https:\/\/breastcancertrialtalk.org\/wp-content\/uploads\/Special-Topics-5-300x179.png\" alt=\"\" width=\"300\" height=\"179\" \/><span style=\"font-size: 12pt; color: #333333;\">On December 15, 2025, the FDA expanded approval for fam-trastuzumab deruxtecan-nxki (Enhertu\u00ae, Daiichi Sankyo, Inc.) in combination with pertuzumab (Perjeta\u00ae) as first-line treatment of people with HER2-positive advanced or metastatic breast cancer. The approval includes a companion diagnostic test for selecting potentially eligible people. This approval is based on results from the phase III DESTINY-Breast09 clinical trial.<\/span><\/p>\n<h6><span style=\"font-size: 12pt; color: #333333;\"><b>Fam-Trastuzumab Deruxtecan-Nxki (Enhertu\u00ae) for First-Line Treatment of HER2+ MBC<\/b><\/span><\/h6>\n<ul>\n<li><span style=\"font-size: 12pt;\"><span style=\"color: #333333;\">US Food and Drug Administration:<\/span> <span style=\"color: #339966;\"><a style=\"color: #339966;\" href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive\" target=\"_blank\" rel=\"noopener\">FDA approves fam-trastuzumab deruxtecan-nxki (Enhertu\u00ae) with pertuzumab (Perjeta\u00ae) as first-line treatment for HER2+ MBC<\/a><\/span><\/span><\/li>\n<\/ul>\n<h6><span style=\"font-size: 12pt;\"><span style=\"color: #333333;\"><b>Clinical Trials for<\/b><b> Fam-Trastuzumab Deruxtecan-Nxki (Enhertu\u00ae)<\/b><\/span><\/span><\/h6>\n<ul>\n<li><span style=\"font-size: 12pt;\"><span style=\"color: #333333;\">Metastatic Trial Search:<\/span> <span style=\"color: #339966;\"><a style=\"color: #339966;\" href=\"https:\/\/www.breastcancertrials.org\/bct_nation\/mts\/mtsResult.seam?zip=94107&amp;yob=0&amp;searchTerm1=trastuzumab&amp;radiusMiles=-1\" target=\"_blank\" rel=\"noopener\">Trials for fam-trastuzumab deruxtecan-nxki (Enhertu\u00ae)<\/a><\/span><\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The FDA expanded approval for fam-trastuzumab deruxtecan-nxki (Enhertu\u00ae) in combination with pertuzumab (Perjeta\u00ae) as first-line treatment of people with HER2+ MBC. Click to learn more about this new approval. <\/p>\n","protected":false},"author":1,"featured_media":6825,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_genesis_block_theme_hide_title":false,"footnotes":""},"categories":[6],"tags":[39,62],"class_list":{"0":"post-8022","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","6":"hentry","7":"category-special-topics","8":"tag-fda-approval","9":"tag-navigating-cancer-care","11":"with-featured-image"},"featured_image_src":"https:\/\/breastcancertrialtalk.org\/wp-content\/uploads\/2023\/11\/Special-Topics-5.png","featured_image_src_square":"https:\/\/breastcancertrialtalk.org\/wp-content\/uploads\/2023\/11\/Special-Topics-5.png","author_info":{"display_name":"bctt","author_link":"https:\/\/breastcancertrialtalk.org\/?author=1"},"_links":{"self":[{"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=\/wp\/v2\/posts\/8022","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=8022"}],"version-history":[{"count":0,"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=\/wp\/v2\/posts\/8022\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=\/wp\/v2\/media\/6825"}],"wp:attachment":[{"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=8022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=8022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/breastcancertrialtalk.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=8022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}