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Pangea Laboratory Receives FDA Breakthrough Device Designation for the Bladder CARE™ Assay

Pangea Laboratory Receives FDA Breakthrough Device Designation for the Bladder CARE™ Assay
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Extended lymph node removal does not benefit

An extended lymphadenectomy – removal of additional lymph nodes beyond the extent of the standard procedure – in patients undergoing radical cystectomy (removal of bladder and nearby tissues) because of clinically localized muscle-invasive bladder cancer provides no patient benefit as measured by disease-free survival or overall survival times. It does, however, increase the risk of adverse events (side effects) and post-surgical death. These primary results from the phase 3 SWOG S1011 clinical trial are being delivered in an oral presentation at the 2023 annual meeting of the American Society of Clinical Oncology in Chicago on June 5 (Abstract 4508).

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TAR-200 Produces High CR Rates, Tolerability in BCG-unresponsive NMIBC

Treatment with TAR-200 produced complete responses and was well tolerated in patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer, according to preliminary data from the phase 2b SunRISe-1 trial.

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Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer

Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer
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