Clinical

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Based 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.

Nivolumab Granted Priority Review as Adjuvant Therapy for Muscle-Invasive Urothelial Carcinoma

Accelerated 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. 

ODAC Decision Means Atezolizumab Will Maintain It’s Indication for Frontline Urothelial Carcinoma 

ONCOLOGY reviews key updates in the treatment of renal cell carcinoma to come out of the Genitourinary Cancers Symposium.

New Potential Frontline Standards for RCC Are Spotlighted at Genitourinary Cancers Symposium

Based on results from the EV-301 and EV-201 trials, 2 separate applications for enfortumab vedotin as therapy for certain patients with previously treated metastatic urothelial carcinoma were accepted by the FDA and granted priority review. 

Priority Review Granted to Two Applications for Enfortumab Vedotin in Metastatic Urothelial Carcinoma

Based on results of the phase 2 TROPHY-U-01 trial, the FDA has given accelerated approval to sacituzumab govitecan for previously treated, locally advanced or metastatic urothelial carcinoma.

FDA Grants Accelerated Approval to Sacituzumab Govitecan for Metastatic Urothelial Cancer 

Leonard 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®.

Updated Standard Practice for Managing Patients with Non-Muscle-Invasive Bladder Cancer

Scott 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®.

Management of Upper Tract Urothelial Tumors With Conservative Management, Mitomycin Gel

As 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. 

Atezolizumab Indication in US Withdrawn for Previously Treated Metastatic Urothelial Cancer

Data published in The Lancet Oncology found that a hypofractionated radiation schedule of 55 Gy in 20 fractions is noninferior to a schedule of 64 Gy in 32 fractions for patients with this disease.

Lower-Dose Hypofractionated Radiotherapy Schedule Proves Effective for Patients With Locally Advanced Bladder Cancer

Continued approval for durvalumab in previously treated adult patients with locally advanced or metastatic bladder cancer was dependent upon results from the phase 3 DANUBE trial in the first-line metastatic bladder cancer setting, which did not meet its primary end points in 2020.

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