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Johnson & Johnson’s TAR-200 Granted FDA Breakthrough Status for High-Risk Bladder Cancer

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Johnson & Johnson received FDA Breakthrough Therapy Designation (BTD) for TAR-200, a promising treatment for high-risk non-muscle-invasive bladder cancer (HR-NMIBC) patients unsuitable for radical cystectomy. This innovative system aims to deliver sustained local gemcitabine release into the bladder. The BTD, marking its 13th in oncology, recognizes the potential of TAR-200 in revolutionizing bladder cancer treatment.

TAR-200’s Potential in Revamping Localized Bladder Cancer Treatment

Dr. Kiran Patel, Vice President of Clinical Development in Solid Tumors at Johnson & Johnson, emphasized TAR-200’s significance in offering a novel approach for localized bladder cancer, an area with limited treatment options, notably outdated BCG therapy or radical cystectomy. The designation represents a promising step in their commitment to reshape bladder cancer treatment.

Bladder Cancer

TAR-200’s Promising Interim Results in BCG-Unresponsive HR-NMIBC

The BTD is backed by data from SunRISe-1, an open-label Phase 2b study assessing TAR-200’s safety and effectiveness in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC patients with carcinoma in situ (CIS). These results were presented at notable medical congresses, highlighting promising interim outcomes. The FDA grants BTD to expedite the development and review of medications for serious or life-threatening conditions, relying on early clinical data suggesting substantial improvement over existing therapies.

SunRISe-1 aims to evaluate TAR-200 in cohorts receiving TAR-200 with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC patients with CIS, focusing on response rate and secondary outcomes like duration of response and overall survival. TAR-200 is an investigational targeted system designed to release gemcitabine into the bladder over weeks, currently undergoing Phase 2 and Phase 3 evaluations in patients with both muscle-invasive and non-muscle-invasive bladder cancers.


Resource: Johnson and Johnson, December 05, 2023

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