FDA Grants Fast Track Designation for TAR-200 in Muscle-Invasive Bladder Cancer

On April 3, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAR-200, a gemcitabine-releasing intravesical system (GemRIS), for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative-intent therapy. This designation offers TARIS earlier and more frequent opportunities to collaborate with the FDA to expedite the development and availability of TAR-200. This status also provides an opportunity for Priority Review and submission of completed sections of a new drug application on a rolling basis prior to completion of the full application.

TAR-200 is designed to release gemcitabine continuously in the bladder for multiple weeks. Earlier this year, TARIS announced initiation of a clinical study of TAR-200 in patients with muscle-invasive bladder cancer who are unfit for curative-intent therapy. Further, the company announced the commencement of a research collaboration with Sweden’s Uppsala Clinical Research Center and Per-Uno Malmström, MD, PhD, to understand the natural history of this patient population.

About Muscle-Invasive Bladder Cancer

Bladder cancer is the fifth most common neoplasm in industrialized countries, affecting roughly 2.7 million people worldwide. In the United States, there were an estimated 79,000 new cases and nearly 17,000 deaths in 2017. Muscle-invasive bladder cancer accounts for 20% to 25% of the newly diagnosed cases and the majority of disease-related mortality.

While some potentially curative treatments—including surgical organ removal and chemoradiation—are available, 40% or more of patients with muscle-invasive bladder cancer are unfit to undergo these morbid procedures or opt to not receive them. Available treatment options for these patients are limited to palliative care.


The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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