Johnson & Johnson's Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation For The Treatment Of High-Risk Non-Muscle-Invasive Bladder Cancer
Portfolio Pulse from Benzinga Newsdesk
The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to Johnson & Johnson's TAR-200 for the treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC). TAR-200 is an investigational targeted releasing system for sustained local release of gemcitabine. The designation is based on data from the ongoing Phase 2b SunRISe-1 study, which also evaluates cetrelimab, a PD-1 monoclonal antibody. The BTD aims to expedite the development and review of treatments for serious conditions showing substantial improvement over existing therapies.
December 04, 2023 | 9:33 pm
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Johnson & Johnson's TAR-200 received FDA Breakthrough Therapy Designation for HR-NMIBC, indicating a significant step in its development and potential future revenue stream.
The FDA's Breakthrough Therapy Designation for TAR-200 suggests a positive outlook for the drug's development pathway and potential market entry. This news is likely to be viewed favorably by investors, as it not only validates the drug's potential but also may lead to an accelerated approval process. Given the serious nature of HR-NMIBC and the limited treatment options currently available, TAR-200 could represent a significant advancement and a new revenue source for Johnson & Johnson if it reaches the market.
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