Pharma Focus Asia

Johnson & Johnson Introduces Breakthrough TAR-200 Therapy for Non-Muscle-Invasive Bladder Cancer

Johnson & Johnson has unveiled TAR-200 therapy, aimed at potentially treating individuals diagnosed with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) that doesn't respond to Bacillus Calmette-Guérin (BCG) treatment.

TAR-200 is an innovative investigational targeted releasing system devised specifically to offer continual local release of gemcitabine into the bladder. 

This approach becomes crucial in situations where treatment options are limited, often restricted to outdated BCG therapy or radical cystectomy, especially for individuals dealing with bladder cancer.

TAR-200, an investigational targeted releasing system, facilitates the controlled and prolonged release of gemcitabine directly into the bladder, ensuring sustained local drug exposure for extended periods, often spanning weeks. 

The SunRISe-1 trial (NCT04640623) is a phase 2b clinical study designed to assess the safety and effectiveness of several treatment approaches for individuals diagnosed with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS). 

This study aims to evaluate the use of TAR-200 in combination with cetrelimab, TAR-200 alone, and cetrelimab alone. These treatments are being investigated in patients who cannot undergo or have chosen not to undergo radical cystectomy. The trial seeks to determine the efficacy and safety profiles of these treatments for this specific patient population.

High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a subtype of non-invasive bladder cancer with a higher tendency for recurrence and potential progression to invasive stages compared to low- and intermediate-risk NMIBC. Comprising 15–44% of NMIBC cases, HR-NMIBC is marked by high-grade tumours, larger tumour sizes, multiple tumour presence, and the existence of carcinoma in situ (CIS). 

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