From the Desk of Evan Yu: “Is HER2 Still a Worthwhile Therapeutic Target for Urothelial Bladder Cancer?”

Whenever the term, HER2, is mentioned, people immediately think, “breast cancer.” With the regulatory approvals of trastuzumab and ado-trastuzumab emtansine, oncologists now have multiple approaches to address HER2 amplified breast cancers. However, HER2 overexpression in gastric cancer has also led to a demonstration of trastuzumab treatment benefit in that disease. We’ve often heard about HER2 […]

Results from Blue Earth Diagnostics’ FALCON Trial Show 64% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Following 18F-Fluciclovine PET/CT Scan

San Francisco, CA (UroToday.com) — Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, announced results from an investigational clinical trial (“FALCON”) evaluating the impact of 18F-fluciclovine PET/CT imaging on the clinical management of men with biochemically recurrent prostate cancer eligible for salvage therapy. The FALCON trial is a UK-based, prospective, multi-center, open-label study […]

Seattle Genetics and Astellas Announce US FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

San Francisco, CA (UroToday.com) — Seattle Genetics, Inc. and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin and granted Priority Review for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have […]

An Open-label, Single-arm, Single-center, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in Subjects With HER2-negative Metastatic or Unresectable Urothelial Cancer

An Open-label, Single-arm, Single-center, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in Subjects With HER2-negative Metastatic or Unresectable Urothelial Cancer Condition: Urothelial Carcinoma Intervention: Drug: RC48-ADC Purpose: This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or […]

A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer

A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer Condition: Urothelial Carcinoma Intervention: Drug: RC48-ADC Purpose: This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with HER2 overexpressing locally advanced or metastatic urothelial cancer. […]

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer Condition: Breast Cancer, Urothelial Carcinoma Intervention: Drug: Trastuzumab deruxtecan (DS-8201a) Drug: Nivolumab Purpose: This is a study of DS-8201a, which […]

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