The FDA has approved nadofaragene firadenovec-vncg (Adstiladrin®, Ferring Pharmaceuticals) for treatment of high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Nadofaragene firadenovec-vncg is a non-replicating adenoviral vector-based gene therapy that cannot multiply in human cells and the first gene therapy to be approved for high-risk NMIBC. "BCG is the most effective therapy for h...
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 ...
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...
The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical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...
Researchers have developed an accurate, noninvasive diagnostic test that can be used for a number of cancers. Their success in applying this test to the detection of bladder cancer makes it the first to effectively utilize atomic force microscopy (AFM) for diagnostic purposes. Bladder cancer is one of the most common cancers and one of the most common causes of cancer-related death. If it is detected in stage 0, bladder cancer has a five-year survival rate of 98%; if it is detected at an advance...
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...
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...
High-grade non–muscle-invasive bladder cancer that does not respond to intravesical Bacillus Calmette-Guerin (BCG) therapy carries a substantial risk of disease recurrence and progression, and effective salvage intravesical therapies are sorely needed for patients who are unable or unwilling to undergo cystectomy. According to results of a multicenter, open-label phase 3 trial presented in February at the American Society of Clinical Oncology (ASCO) 2020 Genitourinary Cancers Symposium, intrave...
Intravesical nadofaragene firadenovec is an effective and well-tolerated treatment for high-grade nonmuscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) that does not respond to intravesical Bacillus Calmette-Guerin (BCG), according to results of a multicenter, open-label phase 3 trial presented this past Friday at the 2020 Genitourinary Cancers Symposium. For patients with BCG-unresponsive NMIBC, there is a substantial risk of disease recurrence and progression. Cystectomy is often ...
The FDA has approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with high-risk non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary tumors. Pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, is indicated for patients who are ineligible for or have elected not to receive radical cystectomy and who do not respond to bacillus Calmette-Guérin (BCG) therapy. The approval was based on Keynote 057 (NCT02625961), a multicenter, singl...
Researchers discovered that the transcription factor protein Engrailed-2 (EN2), which forms boundaries and guides neurons in development, also plays a role in cancer: tumors secrete EN2, which is then taken up by the surrounding normal cells, preventing immune invasion. Lead researcher Richard Morgan, PhD, Professor of Molecular Oncology at the University of Bradford, remarked, "For tumors to survive, grow bigger, and spread, they need to control the behavior of cancer cells and the normal cells...
Erdafitinib (Balversa™, Janssen Pharmaceutical Companies) was recently granted FDA approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Erdafitinib targets genetic alterations that occur in FGFRs, which regulate important biological processes, including cell g...
One of the biggest risk factors for bladder cancer is smoking. Evidence has shown that former smokers have a reduced risk of bladder cancer compared with current smokers, but how long does it take after quitting for that risk to decrease, and how much does the risk decrease compared with that of never-smokers? According to a new study analyzing bladder cancer risk in postmenopausal women, former smokers' bladder cancer risk decreases by 25% within the first 10 years after quitting and continues ...
Many viruses, including herpes simplex virus, adenovirus, vaccinia virus, measles virus, and others, have been developed into oncolytic agents that are able to kill cancer cells while sparing normal cells. Scientists have just discovered that another virus, coxsackievirus, is a potential oncolytic agent that can be used to fight bladder cancer. Coxsackievirus is part of the Enterovirus genus, which also includes poliovirus and echovirus. This virus usually causes fever, skin rash, sore throat, a...
A new technique that utilizes liquid biopsies and conditional reprogramming has the potential to offer personalized treatment strategies for patients with bladder cancer. Accounting for approximately 17,000 deaths in the United States in 2018, bladder cancer is distinctive from many other cancers in that its survival rates have not improved in the past 30 years. Treatment regimens vary due to their dependency on associated risk factors and each patient's personal clinical characteristics. Invest...
The phase 2 California Cancer Consortium trial has reported its final results: a combined regimen of gemcitabine (Gemzar®, Eli Lilly) plus eribulin (Halaven®, Eisai Inc.) shows efficacy in patients with metastatic urothelial carcinoma who are ineligible for cisplatin-based treatment. Many patients with urothelial carcinoma—the most common type of bladder cancer—that has metastasized are ineligible for chemotherapy treatments containing cisplatin. As such, alternatives are needed for th...