June 3rd 2025
The addition of CAN-2409 to a prodrug and radiation therapy in intermediate-to-high-risk prostate cancer significantly improved cancer-specific outcomes.
Nivolumab Granted Priority Review as Adjuvant Therapy for Muscle-Invasive Urothelial Carcinoma
April 30th 2021Based on results of the recently reported phase 3 CheckMate 274 trial, the FDA has granted priority review designation to nivolumab for the adjuvant treatment of high-risk muscle-invasive bladder cancer.
ODAC Decision Means Atezolizumab Will Maintain It’s Indication for Frontline Urothelial Carcinoma
April 29th 2021Accelerated approval for atezolizumab in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for certain chemotherapy regimens was maintained by an FDA committee vote.
Updated Standard Practice for Managing Patients with Non-Muscle-Invasive Bladder Cancer
March 13th 2021Leonard G. Gomella, MD, FACS, detailed updated information regarding the standard of care and overall management of patients with non-muscle invasive bladder cancer at the 2021 New York GU 14th Annual Interdisciplinary Prostate Cancer Congress®.
Management of Upper Tract Urothelial Tumors With Conservative Management, Mitomycin Gel
March 12th 2021Scott G. Hubosky, MD, of Jefferson University Hospitals, discussed methods of treating patients with upper tract urothelial carcinoma at the 2021 New York GU 14th Annual Interdisciplinary Prostate Cancer Congress®.
Atezolizumab Indication in US Withdrawn for Previously Treated Metastatic Urothelial Cancer
March 8th 2021As part of an industry-wide assessment of indications based on accelerated approval, Roche in consultation with the FDA has decided to withdraw the indication for atezolizumab in patients with urothelial carcinoma following platinum-based chemotherapy.
FDA Grants Priority Review to BLA for Vicineum for Treatment of High-Risk, BCG-Unresponsive NMIBC
February 18th 2021The biologics license application is for the locally administered fusion protein Vicineum for the treatment of high-risk, bacillus Calmette-Guérin (BCG)–unresponsive non-muscle invasive bladder cancer.
FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC
February 13th 2020The FDA approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.