The Food and Drug Administration has granted accelerated approval to nivolumab for 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 a platinum-containing chemotherapy.
Approval was based on objective response rate (ORR) in a single-arm study of 270 patients with locally advanced or metastatic urothelial carcinoma who progressed during or following platinum-containing chemotherapy, or progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients received nivolumab, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The ORR was 19.6% (53/270; 95% confidence interval, 15.1-24.9), according to a written statement from the FDA.
Seven patients had complete responses, and 46 had partial responses. Estimated median response duration was 10.3 months with responses ongoing at data cutoff.
Fourteen patients died from causes other than disease progression, including four who died from pneumonitis or cardiovascular failure attributed to nivolumab, the FDA said.
The most common adverse reactions were fatigue, musculoskeletal pain, nausea, and decreased appetite. Adverse reactions led to dose discontinuation in 17% of patients.
The recommended dose and schedule for nivolumab for the above indication is 240 mg intravenously every 2 weeks.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, melanoma, and squamous cell carcinoma of the head and neck.