{"id":14744,"date":"2023-08-23T22:59:00","date_gmt":"2023-08-23T14:59:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14744"},"modified":"2024-11-24T23:03:20","modified_gmt":"2024-11-24T15:03:20","slug":"european-commission-grants-conditional-approval-for-janssens-talvey-in-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14744","title":{"rendered":"European Commission Grants Conditional Approval for Janssen&#8217;s Talvey in Multiple Myeloma"},"content":{"rendered":"\n<p>The European Commission (EC) has granted conditional approval to Johnson &amp; Johnson&#8217;s (J&amp;J; NYSE: JNJ) subsidiary, Janssen, for its innovative GPRC5D\/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This first-in-class treatment is designated for adults with relapsed or refractory multiple myeloma (r\/rMM) who have shown disease progression after at least three prior lines of therapy. The approval is based on the response rate and durability of response data from a Phase I\/II study and is subject to confirmation from future trials.<\/p>\n\n\n\n<p><strong>Talvey&#8217;s Mechanism of Action and Administration<\/strong><br>Talvey works by binding CD3 on T cells, guiding the lymphocytes towards GPRC5D expressed on the surface of multiple myeloma (MM) cells. The treatment can be administered weekly or biweekly following an initial step-up phase, offering a flexible treatment option for patients.<\/p>\n\n\n\n<p><strong>Accelerated Approval in the US and Breakthrough Designation in China<\/strong><br><a href=\"https:\/\/flcube.com\/\">Fineline Info &amp; Tech<\/a> data indicates that the EC&#8217;s decision follows the accelerated approval of Talvey in the US earlier this month. Furthermore, the drug is on track to receive a breakthrough therapy designation (BTD) in China for a similar indication, highlighting its potential as a significant treatment option in the global fight against multiple myeloma.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission (EC) has granted conditional approval to Johnson &amp; Johnson&#8217;s (J&amp;J; NYSE: JNJ)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,1852,150,1996,149,28,858,25,15],"class_list":["post-14744","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-conditional-approvals","tag-jj","tag-janssen","tag-johnson-johnson","tag-multi-specific-antibodies","tag-nyse-jnj","tag-potential-first-in-class","tag-product-approvals"],"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>European Commission Grants Conditional Approval for Janssen&#039;s Talvey in Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The European Commission (EC) has granted conditional approval to Johnson &amp; Johnson&#039;s (J&amp;J; NYSE: JNJ) subsidiary, Janssen, for its innovative GPRC5D\/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This first-in-class treatment is designated for adults with relapsed or refractory multiple myeloma (r\/rMM) who have shown disease progression after at least three prior lines of therapy. The approval is based on the response rate and durability of response data from a Phase I\/II study and is subject to confirmation from future trials.\" \/>\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=14744\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission Grants Conditional Approval for Janssen&#039;s Talvey in Multiple Myeloma\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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