FDA Grants Opdivo Accelerated Approval For Urothelial Carcinoma

The expanded approval was based on results from a study of 270 patients
The expanded approval was based on results from a study of 270 patients

The Food and Drug Administration (FDA) has approved Opdivo (nivolumab; Bristol-Myers Squibb) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-based chemotherapy or for those who have disease progression within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy.  

The expanded approval was supported by the outcomes from a single-arm study (n=270) that assessed the efficacy of Opdivo in patients with locally advanced or metastatic urothelial carcinoma who had experienced disease progression during or after receiving platinum-based chemotherapy and in patients whose disease had progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. Objective response rate was confirmed to be 19.6% (95% CI: 15.1, 24.9). Of the 270 patients, seven had complete responses and 46 had partial responses. The median duration of response was 10.3 months (range: 1.9–12 months) and the median time to response was 1.9 months (range: 1.6–7.2). 

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Opdivo, a programmed death receptor-1 (PD-1), is also approved for the treatment of patients with unresectable or metastatic melanoma, metastatic non-small cell lung cancer, advanced renal cell carcinoma, Classical Hodgkin lymphoma, and recurrent or metastatic squamous cell carcinoma of the head and neck.

 Opdivo is available as 40mg/4mL and 100mg/10mL strength single-dose vials.

 For more information call (800) 721-5072 or visit Opdivo.com.

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