{"id":30866,"date":"2025-03-28T16:50:23","date_gmt":"2025-03-28T08:50:23","guid":{"rendered":"https:\/\/flcube.com\/?p=30866"},"modified":"2025-03-28T16:51:21","modified_gmt":"2025-03-28T08:51:21","slug":"genmabs-tivdak-approved-in-japan-for-advanced-cervical-cancer-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30866","title":{"rendered":"Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment"},"content":{"rendered":"\n

Denmark-based Genmab A\/S (NASDAQ: GMAB<\/a>) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. <\/p>\n\n\n\n

Drug Profile and Technology<\/strong>
Tivdak is an antibody-drug conjugate (ADC) comprising Genmab\u2019s human monoclonal antibody directed to tissue factor (TF) and Seagen\u2019s ADC technology. It uses a protease-cleavable linker to attach the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody, ensuring targeted delivery and enhanced efficacy.<\/p>\n\n\n\n

Licensing and Regulatory Milestones<\/strong>
China\u2019s Zai Lab Limited (NASDAQ: ZLAB<\/a>, HKG: 9688<\/a>) acquired development and commercialization rights for Tivdak in Greater China through a licensing deal with Seagen, now part of Pfizer, in September 2022. The drug received full FDA approval in April 2024 for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on or after chemotherapy.<\/p>\n\n\n\n

Clinical Trial Success<\/strong>
The approval in Japan, which makes Tivdak the first and only ADC for cervical cancer in the country, was supported by the Phase III innovaTV 301 study involving 502 patients. Compared to chemotherapy, Tivdak reduced the risk of death by 30%, significantly improved median overall survival (11.5 months vs. 9.5 months), and demonstrated good safety.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Denmark-based Genmab A\/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour…<\/p>\n","protected":false},"author":1,"featured_media":30867,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[35,869,851,868,309,15,1735,413],"class_list":["post-30866","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-hkg-9688","tag-nasdaq-gmab","tag-nasdaq-zlab","tag-pfizer","tag-product-approvals","tag-seagen","tag-zai-lab"],"yoast_head":"\nGenmab's Tivdak Approved in Japan for Advanced Cervical Cancer Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Denmark-based Genmab A\/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy.\" \/>\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=30866\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Genmab's Tivdak Approved in Japan for Advanced Cervical Cancer Treatment\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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