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FDA grants accelerated approval to Opdivo for urothelial carcinoma
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The FDA granted accelerated approval to nivolumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who experienced disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
The approval is based, in part, on results of a single-arm study that evaluated nivolumab (Opdivo, Bristol-Myers Squibb) in 270 patients. Patients received 3 mg/kg of nivolumab every 2 weeks until disease progression or unacceptable toxicity.
Patients demonstrated an overall response rate of 19.6% (95% CI, 15.1-24.9). Seven patients achieved complete responses and 46 patients achieved partial responses over a median response duration of 10.3 months, with responses ongoing at data cutoff.
The most common adverse events included fatigue, musculoskeletal pain, nausea and decreased appetite.
Fourteen patients died of other causes — including four patients who died of pneumonitis or cardiovascular failure attributed to nivolumab treatment.
Adverse events led to dose discontinuation in 17% of patients.
The FDA recommended a dose and schedule of 240 mg of nivolumab intravenously every 2 weeks.