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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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United States , Abigail Kang , Larry Jia , Siamak Daneshmand , Hooman Djaladat , Paolo Piatti , Clinical Research , Prnewswire Pangea Laboratory , Pangea Laboratory , Clinical Laboratory Improvement Amendments , Institute Of Urology , College Of American Pathologists , Drug Administration , Promising Advancement , Early Detection , Breakthrough Device Designation , Clinical Scholar , Project Manager , Laboratory Improvement Amendments , American Pathologists ,

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). ....

United States , Franciscog Larosa , Ianm Thompson Jr , Ajai Alva , Sumantak Pal , Roberts Svatek , Adams Kibel , Wassim Kassouf , Kamal Pohar , Aashish Kamat , Sethp Lerner , Theresam Koppie , Arthuri Sagalowsky , Siamak Daneshmand , Catherine Tangen , Anne Schuckman , Dave Swalm , City Of Hope Medical Center , National Institutes Of Health , University Of Texas Health San Antonio , Stanford University , Md Anderson Cancer Center , Mcgill University Health Center , American Society Of Clinical Oncology , Ohio State University , Community Oncology Research Program ,

Novel Chemo Delivery System Achieves High Response Rate in Bladder Cancer

Complete responses in 73% of patients with BCG-unresponsive non-muscle-invasive disease ....

United States , Los Angeles , Mike Bassett , Siamak Daneshmand , American Urological Association , Keck School , Southern California , American Urological ,

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. ....

United States , Siamak Daneshmand , American Urological Association Annual Meeting , Clinical Research , Bacillus Calmette Gu , Urological Association Annual , Keck Medicine , Patients With Bacillus Calmette Guérin Unresponsive , High Risk Non Muscle Invasive Bladder Cancer , Tar 200 , Phase 2b Sunrise 1 Trial , Localized Gemcitabine , Novel Intravesical Delivery System ,

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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United States , Siamak Daneshmand , Indianj Urol , World Health Organization , Janssen Pharmaceutical Companies Of Johnson , Janssen Pharmaceutical Companies , Companies Of Johnson , None Of Janssen Research Development , American Urological Association Annual Meeting , Cancer Treatment Centers Of America , Drug Administration , Exchange Commission , Norris Comprehensive Cancer Center , Janssen Biotech Inc , American Cancer Society , Janssen Research Development , Janssen Reports First Results , Bacillus Calmette Gu , Unresponsive Non Muscle Invasive Bladder , Late Breaker Podium Presentation Session , Urologic Oncology , Keck School , Southern California , Christopher Cutie , Vice President , Disease Area Leader ,