FDA Approves Pembrolizumab for Advanced/Metastatic Urothelial Carcinoma

The FDA has granted regular approval to pembrolizumab (Keytruda®, Merck) for the first-line treatment of patients with locally advanced/metastatic urothelial carcinoma who are ineligible for platinum-containing chemotherapy. This regular approval comes after the FDA granted pembrolizumab accelerated approval. "Programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors are active in metastatic urothelial carcinoma," wrote Thomas Powles, MD, Professor of Genitourinary ...
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FDA Approves Sacituzumab Govitecan for Advanced Urothelial Cancer

Sacituzumab govitecan (Trodelvy®, Immunomedics) has been granted accelerated approval for patients with locally advanced or metastatic urothelial cancer following treatment with platinum–containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitor. "Patients with metastatic urothelial cancer have limited options after progression on platinum and checkpoint inhibitors," wrote the investigators of the phase 2 TROPHY-U-01 study (NCT03547973), on w...
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FDA Issues Draft Guidances for Bladder Cancer, Renal Cell Carcinoma

The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical trials concerning eligibility criteria, methodology, and use of disease-free survival as an end point. "The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer, including hosting a public workshop in p...
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E-Cigarettes and Bladder Cancer Risk: Marc Bjurlin, DO, MSc

Despite their known pulmonary, neurological, and carcinogenic risks, electronic cigarette (e-cigarette) use has increased drastically in recent years, especially among adolescents and young adults. In a recent study, a team of researchers led by Marc Bjurlin, DO, MSc, Associate Professor of Urology at the University of North Carolina Chapel Hill's Lineberger Comprehensive Cancer Center, analyzed the urine samples of e-cigarette users and identified the presence of several carcinogenic biomarkers...
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Could E-Cigarettes Cause Bladder Cancer?

According to the results of a recently published study, carcinogenic biomarkers strongly linked to bladder cancer risk are found in the urine samples of electronic cigarette (e-cigarette) users. E-cigarettes contain nicotine, additives, and other chemical solvents that can create numerous toxic compounds when heated. Their popularity has increased dramatically in recent years, especially in the adolescent and young adult population. Between 2017 and 2018, usage increased nearly 80% among high sc...
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