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# J&J Breakthrough Status on Bladder Cancer Drug
- URL: https://www.fdaweb.com/j-j-breakthrough-status-on-bladder-cancer-drug/
- Published: 2023-12-04T12:00:00.000Z
- Updated: 2026-09-14T14:17:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155915

FDA has granted Johnson & Johnson a breakthrough therapy designation for TAR-200 for treating patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for or elected not to undergo bladder removal. The company describes TAR-200 as a “novel investigational targeted releasing system designed to provide sustained local release of gemcitabine into the bladder.”

The designation is based on data from the SunRISe-1 ([NCT04640623](https://c212.net/c/link/?t=0&l=en&o=4041439-1&h=1879691917&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04640623&a=NCT04640623&ref=fdaweb.com)) Phase 2b clinical study evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC carcinoma *in situ* patients. The primary endpoint is complete response rate, and secondary endpoints include duration of response, overall survival, pharmacokinetics, quality of life, safety, and tolerability, according to the company.

Intravenous cetrelimab is an investigational programmed cell death receptor-1 monoclonal antibody being evaluated for treating bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination regimen, according to Johnson & Johnson.