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FDA grants fast track designation to Gem-RIS for muscle-invasive bladder cancer
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The FDA granted fast track designation to TAR-200 for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative intent therapy, according to the agent’s manufacturer.
TAR-200 (GemRIS, TARIS Biomedical) is designed to release the chemotherapeutic agent gemcitabine continually in the bladder for multiple weeks.
"This fast track designation reinforces the high unmet need in the treatment of muscle-invasive bladder cancer patients, especially those who cannot receive curative intent therapy. It further highlights the potential of GemRIS to benefit this underserved population,” Purnanand Sarma, PhD, president and CEO of TARIS, said in a company-issued press release.
An estimated 79,000 new cases of bladder cancer are diagnosed each year in the United States, and approximately 17,000 people die of the disease annually. Muscle-invasive bladder cancer accounts for about one-quarter of newly diagnosed cases and the majority of disease-related mortality.
Potentially curative treatment options include organ removal and chemoradiation; however, approximately 40% of patients with muscle-invasive disease are not fit for these procedures or opt not to undergo them, leaving them with palliative care as their only treatment option.
Earlier this year, TARIS announced initiation of a clinical study of TAR-200 for patients with muscle-invasive bladder cancer who are unfit for curative therapy. The company also launched a research collaboration with Uppsala Clinical Research Center in Sweden designed to improve understanding of the natural history and disease outcomes for these patients.
“Taken together, the combination of fast track, our ongoing clinical study, and our research collaboration in Sweden, form the foundation to rapidly advance the development of GemRIS,” Sarma said. “We look forward to working closely with the FDA to bring this important therapy to patients as quickly as possible.”