Johnson & Johnson Submits NDA for TAR-200 with 84% Complete Response Rate in BCG-Unresponsive HR-NMIBC

▎Armstrong

On January 15, 2025, Johnson & Johnson announced the initiation of a submission for the marketing application of TAR-200, intended for the treatment of high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS) in patients unresponsive to Bacillus Calmette-Guérin (BCG). This submission is part of the Real-Time Oncology Review (RTOR) program, which allows the FDA to begin its review before the complete application is formally submitted to expedite the process.

TAR-200 is a novel delivery system for intravesical local administration, featuring a dual-miniplate design made of semi-permeable silicone polymer tubing, allowing for the sustained and slow release of gemcitabine in the bladder.

According to the SunRISe-1 clinical data presented at last year's ESMO conference, the complete response rate for TAR-200 monotherapy in cohort two was as high as 83.8%. The complete response rate for the Cetrelimab monotherapy group was 46.4%.

Summary

In recent years, there has been an emergence of new drugs for NMIBC. IL-15 was just approved last year, and more new drugs are continuously achieving clinical breakthroughs. In addition to TAR-200, CG Oncology's oncolytic virus therapy CG0070 has demonstrated very impressive efficacy and safety data and has already received Breakthrough Therapy Designation from the FDA. In China, LePu Biopharma holds the Greater China rights to CG0070, which was recently included in the Breakthrough Treatment Drug Program.