FDA Grants Breakthrough Designation to J&J's TAR-200 for Bladder Cancer

Johnson & Johnson's investigational therapy, TAR-200, has earned Breakthrough Therapy Designation from the FDA for high-risk non-muscle-invasive bladder cancer. This innovative approach offers sustained local release of gemcitabine into the bladder, potentially revolutionizing treatment for patients who have not responded to traditional therapies.

Johnson & Johnson announced that its investigational therapy, TAR-200, has earned the prestigious Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for high-risk non-muscle-invasive bladder cancer. This designation is a significant step forward in addressing the pressing medical needs of patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who have not responded to traditional treatments. TAR-200 represents a revolutionary approach to the treatment of localized bladder cancer. The designation is supported by promising data from the ongoing SunRISe-1 study.

Kiran Patel, M.D., Vice President of Clinical Development at J&J IM, mentioned the importance of this development, saying, 

“TAR-200 represents a novel interventional approach for the treatment of localized bladder cancer where today, unfortunately, options are limited and include antiquated BCG therapy or radical cystectomy. This Breakthrough Therapy Designation recognizes TAR-200 as a promising advancement and marks an important step forward in our innovative focus to transform the treatment of bladder cancer.”

The Breakthrough Therapy Designation from the FDA is granted to expedite the development and regulatory review of a medicine intended to treat a serious or life-threatening condition. It is based on preliminary clinical evidence that demonstrates the drug may offer substantial improvements over available therapies, addressing clinically significant endpoints.

High-Risk Non-Muscle-Invasive Bladder Cancer

High-risk non-muscle-invasive bladder cancer (HR-NMIBC) presents a significant management challenge. This type of cancer carries a higher risk of recurrence, spreading beyond the bladder lining, and progressing to a more invasive form compared to other types of bladder cancer.

This designation comes following promising data from the ongoing Phase 2b SunRISe-1 study (NCT04640623). The study evaluates 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 (CIS) patients who are ineligible for or have chosen not to undergo radical cystectomy. The results of the SunRISe-1 study were presented at the 2023 European Society for Medical Oncology Annual Congress and the 2023 American Urological Association Annual Meeting.

The Breakthrough Therapy Designation granted to TAR-200 underscores the urgent need for innovative and effective treatments for high-risk non-muscle-invasive bladder cancer. It represents a beacon of hope for patients and a testament to the remarkable progress being made in the field of oncology.

About Author: Tracy Mokwe

With over 3 years of experience as a medical laboratory scientist and writer, I am passionate about translating complex scientific information into clear and accessible content. My expertise lies in medical sciences, laboratory science and research, digital health, AI, and cybersecurity in healthcare.