Nivolumab Approved for Refractory Urothelial Carcinoma

Nivolumab (Opdivo) injection has received FDA approval for treating patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or after platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In the CheckMate-275 phase 2 open-label trial, 53 (19.6%) of 270 of patients responded to treatment with nivolumab: 7 patients (2.6%) had a complete response and 46 patients (17%) had a partial response, according to a press release from Bristol-Myers Squibb Company, the maker of nivolumab. Among responders, the median time to response was 1.9 months and the median duration of response was 10.3 months.
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In the trial, patients received nivolumab 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity. The recommended dose for mUC is 240 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was objective response rate, as defined by an independent radiographic review committee.

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