▎WuXiEdited by Kant Content Team

Today, Johnson & Johnson announced,The new drug application (NDA) for TAR-200 has been initiated for submission to the U.S. FDA, intended for the treatment of high-risk non-muscle invasive bladder cancer (HR-NMIBC) patients with carcinoma in situ who are unresponsive to Bacillus Calmette-Guérin (BCG).The application is under review through the FDA's Real-Time Oncology Review (RTOR) program.

The application for this innovative intravesical drug delivery system is supported by data from the registrational Phase 2b clinical trial, SunRISe-1. Data collected as of the second quarter of 2024 show,The complete response rate (CR) was 83.5%, with highly durable complete responses achieved without the need for re-induction therapy. At a median follow-up of 9 months, 82% of responding patients maintained their response.As of May 2024, safety and tolerability data showed a low incidence of grade 3 or higher treatment-related adverse events (TRAEs) (9%), with five patients discontinuing treatment due to treatment-related adverse events (6%). No treatment-related deaths were reported.

TAR-200 is an investigational intravesical drug delivery system designed to achieve sustained local release of gemcitabine in the bladder, maintaining local drug exposure for up to several weeks.The system is implanted in the bladder by healthcare professionals through a配套的尿道放置导管 in an outpatient setting, with the entire process taking less than five minutes and without the need for anesthesia. In December 2023, the U.S. FDA granted TAR-200Breakthrough Therapy Designation(BTD), used to treat high-risk non-muscle-invasive bladder cancer patients with carcinoma in situ who are unsuitable for or choose not to undergo radical cystectomy and are unresponsive to BCG.

High-risk non-muscle-invasive bladder cancer is a type of non-invasive bladder cancer that is more prone to recurrence or diffusion into the inner layer of the bladder and progression to muscle-invasive bladder cancer. Compared with low-risk non-muscle-invasive bladder cancer, it has a higher risk of progression. Currently, for patients with non-muscle-invasive bladder cancer who fail BCG treatment, radical cystectomy is recommended. If surgery is performed before progression to muscle-invasive bladder cancer, the cancer-specific survival rate exceeds 90%. Considering that non-muscle-invasive bladder cancer usually affects elderly patients, many people are unwilling or unsuitable to undergo radical cystectomy. The high recurrence and progression rates may impose a significant disease burden and psychological distress on these patients.

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