{"id":15256,"date":"2023-08-14T21:29:00","date_gmt":"2023-08-14T13:29:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15256"},"modified":"2024-11-27T21:31:45","modified_gmt":"2024-11-27T13:31:45","slug":"janssens-talvey-receives-fda-accelerated-approval-for-relapsed-refractory-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15256","title":{"rendered":"Janssen’s Talvey Receives FDA Accelerated Approval for Relapsed\/Refractory Multiple Myeloma"},"content":{"rendered":"\n

The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ<\/a>) announced last week that it received accelerated approval from the US Food and Drug Administration (FDA) for its first-in-class GPRC5D\/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This treatment is designated for adults with relapsed or refractory multiple myeloma (r\/rMM) who have undergone at least four prior lines of therapy. The approval is based on data demonstrating response rate and durability of response and is subject to confirmation from future trials.<\/p>\n\n\n\n

Talvey’s Mechanism of Action and Administration<\/strong>
Talvey works by binding CD3 on T cells, guiding the lymphocytes towards GPRC5D expressed on multiple myeloma (MM) cells. This innovative approach harnesses the immune system to target cancer cells. The drug can be administered weekly or biweekly following an initial step-up phase, offering a flexible treatment option for patients.<\/p>\n\n\n\n

Potential Breakthrough Therapy Designation in China<\/strong>
According to Fineline Info & Tech<\/a> data, Talvey is on track to receive a breakthrough therapy designation (BTD) in China for a similar indication. This reflects the global recognition of the drug’s potential impact on the treatment of multiple myeloma and underscores the need for novel therapies in this area.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) announced last week that it…<\/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":[16,150,1996,149,28,858,25],"class_list":["post-15256","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-jj","tag-janssen","tag-johnson-johnson","tag-multi-specific-antibodies","tag-nyse-jnj","tag-potential-first-in-class"],"yoast_head":"\nJanssen's Talvey Receives FDA Accelerated Approval for Relapsed\/Refractory Multiple Myeloma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) announced last week that it received accelerated approval from the US Food and Drug Administration (FDA) for its first-in-class GPRC5D\/CD3 bispecific antibody (BsAb), Talvey (talquetamab). 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