{"id":3865,"date":"2026-06-07T06:34:14","date_gmt":"2026-06-07T13:34:14","guid":{"rendered":"https:\/\/xpharma.com.cn\/?p=3865"},"modified":"2026-06-07T06:34:16","modified_gmt":"2026-06-07T13:34:16","slug":"amgen%ef%bc%9aimdelltratarlatamabwas-approved-in-the-european-union","status":"publish","type":"post","link":"https:\/\/xpharma.com.cn\/index.php\/news\/amgen%ef%bc%9aimdelltratarlatamabwas-approved-in-the-european-union\/","title":{"rendered":"Amgen\uff1aIMDELLTRA\u00aeTarlatamabwas approved in the European Union."},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">On June 1, local time, Amgen announced that the European Commission (EC) has approved its DLL3\/CD3 bispecific antibody IMDYLLTRA\u00ae (tarlatamab) as a monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression during or after first-line platinum-based chemotherapy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This approval is based on positive results from the DeLLphi-304 study (NCT05740566), a randomized, open-label Phase III trial comparing tarlatamab with standard-of-care chemotherapy in patients with relapsed small cell lung cancer following first-line platinum-based chemotherapy. The primary endpoint was overall survival (OS).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The primary analysis results of DeLLphi-304 were presented at the 2025 ASCO Annual Conference. A total of 509 patients were randomized (254 to tarlatamab; 255 to chemotherapy). Data showed that the median follow-up was 11.2 months in the tarlatamab group and 11.7 months in the chemotherapy group. Compared with chemotherapy, tarlatamab demonstrated significantly prolonged OS and progression-free survival (PFS), with a median OS of 13.6 months vs 8.3 months (HR=0.60) and a median PFS of 4.2 months vs 3.2 months (HR=0.72). In terms of safety, the incidence of Grade \u22653 treatment-related adverse events (TRAEs) was lower in the tarlatamab group compared with the chemotherapy group (27% vs 62%), and the rate of TRAE-related treatment discontinuation was also lower (3% vs 6%).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The most common Grade \u22653 TRAEs in the tarlatamab group were neutropenia (4%) and lymphopenia (4%), whereas in the chemotherapy group, the most common Grade \u22653 TRAEs were anemia (28%) and neutropenia (22%). Cytokine release syndrome (CRS) in the tarlatamab group was predominantly low grade (Grade 1: 42%; Grade 2: 13%; Grade 3: 1%) and manageable. According to the Insight database, tarlatamab was first approved in the United States in May 2024 for the treatment of adult patients with ES-SCLC following disease progression on or after platinum-based chemotherapy. In December of the same year, it was approved in Japan, and subsequently received approvals in the United Kingdom, Canada, and other countries and regions in 2025. In China, tarlatamab was first approved by the NMPA in April 2026, with a new indication approved in May 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Buy Imdylltra\u00ae (tarlatamab)\u00a0online from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On June 1, local time, Amgen announced that the European Commission (EC) has approved its DLL3\/CD3 bispecific antibody IMDYLLTRA\u00ae (tarlatamab) as a monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression during or after first-line platinum-based chemotherapy. This approval is based on positive results from [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":3867,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-3865","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"blocksy_meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Amgen\uff1aIMDELLTRA\u00aeTarlatamabwas approved in the European Union. - Xpharma China<\/title>\n<meta name=\"description\" content=\"Amgen\uff1aIMDELLTRA\u00aeTarlatamabwas approved in the European Union. - Xpharma China\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/xpharma.com.cn\/index.php\/news\/amgen\uff1aimdelltratarlatamabwas-approved-in-the-european-union\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amgen\uff1aIMDELLTRA\u00aeTarlatamabwas approved in the European Union. - 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