Bladder Cancer | Clinical

ODAC Votes to Continue Approval of Pembrolizumab For Locally Advanced or Metastatic UC

April 28, 2021

The FDA’s Oncologic Drugs Advisory Committee voted 5 to 3 in favor of continued approval of pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

Avelumab Considered a Gold Standard for Advanced Urothelial Carcinoma After 1L Chemotherapy

April 23, 2021

Avelumab is considered a new standard-of-care treatment for patients with advanced urothelial carcinoma who have not progressed on frontline platinum-containing chemotherapy after the agent demonstrated overall survival improvement for this patient population in a phase 3 clinical trial setting.

Adjuvant Nivolumab Confers 30% Reduction in Disease Recurrence in MIUC

April 22, 2021

Findings from a A phase 3 trial evaluating adjuvant nivolumab following surgery versus placebo demonstrated an improvement in median disease-free survival in patients with muscle-invasive urothelial cancer, according to results from the CheckMate 274 trial presented at the 2021 Genitourinary Cancers Symposium.

FDA Accelerates Approval of Sacituzumab Govitecan in Locally Advanced or Metastatic UC

April 13, 2021

An accelerated approval was granted by the FDA to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.