The US Food and Drug Administration (FDA) has approved intravenous nivolumab (Opdivo) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1

This indication is approved under accelerated approval based on tumor response rate and duration of response. Verification and description of clinical benefit in confirmatory trials may be needed for continued approval for this indication.

“Most people don’t know how common bladder cancer is and that it is the fifth most diagnosed cancer,” Stephanie Chisolm, director of Education and Research at Bladder Cancer Advocacy Network, said in a press release. “This approval is another exciting step forward for the bladder cancer community and provides needed hope to patients and their families.”

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The recommended dose and schedule of nivolumab for urothelial carcinoma is 240 mg administered over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

The most common adverse events occurring in 20% of patients or more are asthenia/fatigue, lymphopenia, anemia, musculoskeletal pain, decreased appetite, and nausea. The most frequent grade 3 to 4 adverse events are asthenia/fatigue, urinary tract infection, lymphopenia, and anemia.

Approval was based on findings from the multicenter, open-label, phase 2 CheckMate-275 trial, which demonstrated an overall response rate of 19.6% (95% CI, 15.1-24.9) among the 270 patients treated with nivolumab. Seven patients achieved a complete response and 46 had partial response. Median duration of response was 10.3 months.

“As an oncologist, a nearly 20% response rate in advanced and metastatic bladder cancer is extremely encouraging and clinically meaningful in this patient population,” Jonathan E. Rosenberg, MD, Memorial Sloan Kettering Cancer Center, said in a statement.


1. Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer [news release]. Princeton, NJ: Bristol-Myers Squibb; February 2, 2017. Accessed February 3, 2017.