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The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical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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Nivolumab/Ipilimumab for Advanced Renal Cell Carcinoma: Meredith Regan, ScD

Patients with advanced renal cell carcinoma (RCC) who receive combination PD-1/CTLA-4 blockade can experience periods of durable benefit and toxicity after treatment discontinuation. According to results of the phase 3 CheckMate 214 trial presented by Meredith Regan, ScD, at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, nivolumab/ipilimumab prolongs treatment-free survival, both with and without toxicity, in patients with previously untreated advanced clear cell RCC. In...
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Advanced Renal Cell Carcinoma: Nivolumab/Ipilimumab Improves Treatment-Free Survival

Nivolumab/ipilimumab prolongs treatment-free survival with and without toxicity in patients with untreated advanced renal cell carcinoma (RCC), according to an updated analysis of the phase 3 CheckMate 214 trial presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. "Conventional measures may not fully characterize the impact of immuno-oncology agents," comment the investigators in their presentation abstract, led by first author Meredith Regan, ScD, Associate Profe...
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Exciting Treatment Advances in Upper Tract Urothelial Cancer: Seth P. Lerner, MD, FACS

Substantial developments are under way in the treatment of upper tract urothelial cancer (UTUC). Seth P. Lerner, MD, FACS, recently spoke with i3 Health about mitomycin gel (JelmytoTM, UroGen Pharma), now FDA approved as the first agent specifically indicated for the treatment of low-grade UTUC. In this second installment of his interview, Dr. Lerner, principal investigator of the OLYMPUS study, on which the mitomycin gel approval was based, discusses research advances in the treatment of both l...
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Mitomycin Gel for Low-Grade Upper Tract Urothelial Cancer: Seth P. Lerner, MD, FACS

Upper-tract urothelial cancer (UTUC) is a rare cancer that often needs to be treated with radical surgery, typically entailing complete removal of the affected kidney, ureter, and bladder cuff. Mitomycin C formulated with a reverse thermal hydrogel (JelmytoTM, UroGen Pharma), recently approved by the FDA as the first agent specifically indicated for the treatment of low-grade UTUC, will now allow some patients to keep a kidney that would otherwise have needed to be removed. In this interview wit...
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