{"id":31311,"date":"2025-04-07T17:28:09","date_gmt":"2025-04-07T09:28:09","guid":{"rendered":"https:\/\/flcube.com\/?p=31311"},"modified":"2025-04-07T17:28:10","modified_gmt":"2025-04-07T09:28:10","slug":"enhertu-approved-by-ec-for-earlier-line-treatment-of-hr-her2-low-breast-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=31311","title":{"rendered":"Enhertu Approved by EC for Earlier-Line Treatment of HR+\/HER2-low Breast Cancer"},"content":{"rendered":"\n<p>Partners AstraZeneca (<a href=\"https:\/\/www.google.com\/finance\/quote\/AZN:NASDAQ\">NASDAQ: AZN<\/a>) and Daiichi Sankyo (<a href=\"https:\/\/www.google.com\/finance\/quote\/4568:TYO\">TYO: 4568<\/a>) announced that they have received approval from the European Commission (EC) for an additional indication for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody-drug conjugate (ADC) is now approved for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer. This approval applies to patients who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.<\/p>\n\n\n\n<p><strong>Mechanism and Approval<\/strong><br>Enhertu is designed to deliver cytotoxic chemotherapy directly to cancer cells that express HER2, leveraging its mechanism to enhance therapeutic efficacy while minimizing systemic exposure. The latest approval expands Enhertu&#8217;s use to earlier-line treatment of HR+\/HER2-low breast cancer and includes patients with HER2-ultralow disease, further broadening its patient population.<\/p>\n\n\n\n<p><strong>Clinical Trial Success<\/strong><br>The approval is based on positive results from the Phase III DESTINY-Breast06 study, which demonstrated that Enhertu significantly reduced the risk of disease progression or death by 38% compared to chemotherapy. Patients treated with Enhertu achieved a median progression-free survival (mPFS) of 13.2 months versus 8.1 months for those receiving chemotherapy.<\/p>\n\n\n\n<p><strong>Global Impact<\/strong><br>Enhertu is now approved in over 75 countries for the treatment of HER2-positive breast cancer, non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction adenocarcinoma (GC\/GEJC), and other solid tumors. This latest approval underscores the drug&#8217;s growing role in oncology care, offering new hope to patients with challenging treatment profiles.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that they have received approval&#8230;<\/p>\n","protected":false},"author":1,"featured_media":31312,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[35,130,16,194,871,15,978],"class_list":["post-31311","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-astrazeneca","tag-cancer","tag-daiichi-sankyo","tag-nasdaq-azn","tag-product-approvals","tag-tyo-4568"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Enhertu Approved by EC for Earlier-Line Treatment of HR+\/HER2-low Breast Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that they have received approval from the European Commission (EC) for an additional indication for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody-drug conjugate (ADC) is now approved for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer. This approval applies to patients who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=31311\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Enhertu Approved by EC for Earlier-Line Treatment of HR+\/HER2-low Breast Cancer\" \/>\n<meta property=\"og:description\" content=\"Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that they have received approval from the European Commission (EC) for an additional indication for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody-drug conjugate (ADC) is now approved for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer. 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