{"id":9729,"date":"2024-01-22T22:25:00","date_gmt":"2024-01-22T14:25:00","guid":{"rendered":"https:\/\/flcube.com\/?p=9729"},"modified":"2024-10-26T22:28:15","modified_gmt":"2024-10-26T14:28:15","slug":"jjs-balversa-receives-full-fda-approval-for-urothelial-carcinoma-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=9729","title":{"rendered":"J&J\u2019s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment"},"content":{"rendered":"\n

The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson\u2019s (J&J; NYSE: JNJ<\/a>) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who have received at least one prior line of systemic therapy. This decision follows positive Phase III clinical trial results, which demonstrated that the first-in-class drug lowered the risk of death by 36% and extended overall survival (OS) by over four months compared to standard chemotherapy, meeting the study\u2019s primary endpoint.- Flcube.com<\/a><\/p>\n\n\n\n

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The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson…<\/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":[16,150,149,858,25,15],"class_list":["post-9729","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-jj","tag-johnson-johnson","tag-nyse-jnj","tag-potential-first-in-class","tag-product-approvals"],"yoast_head":"\nJ&J\u2019s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson\u2019s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. 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