{"id":13004,"date":"2023-10-13T22:03:00","date_gmt":"2023-10-13T14:03:00","guid":{"rendered":"https:\/\/flcube.com\/?p=13004"},"modified":"2024-11-16T22:06:49","modified_gmt":"2024-11-16T14:06:49","slug":"jjs-cetrelimab-and-tar-200-gain-tacit-approvals-for-bladder-cancer-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13004","title":{"rendered":"J&J’s Cetrelimab and TAR-200 Gain Tacit Approvals for Bladder Cancer Trials"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE: JNJ<\/a>) has received two tacit clinical trial approvals for its Category 1 drug cetrelimab combined with TAR-200. The approvals are for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) patients not receiving BCG treatment, and myometrial infiltrating bladder urothelial carcinoma patients who have not undergone total cystectomy.<\/p>\n\n\n\n

Cetrelimab and TAR-200: A Promising Combination<\/strong>
Cetrelimab is a PD-1 monoclonal antibody (mAb) under development by J&J for the treatment of bladder cancer, melanoma, and multiple myeloma. It is administered intravenously and is part of a combination therapy approach. TAR-200 is an innovative bladder drug delivery system designed to release low-dose chemotherapy drug gemcitabine over an extended period.<\/p>\n\n\n\n

Positive Results from Phase II Clinical Trial<\/strong>
The Phase II clinical trial of cetrelimab and TAR-200 in high-risk NMIBC patients who did not respond to BCG has reported positive efficacy and safety results. In the trial, the cetrelimab treatment group achieved a complete remission (CR) rate of 38.1%, while the TAR-200 treatment group reached a CR rate of 72.7%. The combination treatment group’s results are anticipated to be announced subsequently.<\/p>\n\n\n\n

Future Outlook<\/strong>
These tacit approvals from the CDE underscore the potential of J&J’s cetrelimab and TAR-200 in addressing the unmet needs of high-risk bladder cancer patients. The combination therapy’s positive outcomes in the Phase II trial suggest a promising direction for future treatments, offering hope for improved patient outcomes in this challenging disease area.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE:…<\/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":[16,29,150,149,858,18],"class_list":["post-13004","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-combination-therapy","tag-jj","tag-johnson-johnson","tag-nyse-jnj","tag-pd-1-l1"],"yoast_head":"\nJ&J's Cetrelimab and TAR-200 Gain Tacit Approvals for Bladder Cancer Trials - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE: JNJ) has received two tacit clinical trial approvals for its Category 1 drug cetrelimab combined with TAR-200. 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