FDA Approves Nivolumab in Locally Advanced or Metastatic Bladder Cancer

On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to 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 a platinum-containing chemotherapy.

Approval was based on a single-arm study—the CheckMate 275 trial—treating 270 patients with locally advanced or metastatic urothelial carcinoma that 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 objective response rate, confirmed by an independent radiographic review committee using Response Evaluation Criteria in Solid Tumors version 1.1, was 19.6% (53/270; 95% confidence interval = 15.1–24.9). Seven patients had complete responses and 46 had partial responses. Estimated median response duration was 10.3 months with responses ongoing at data cutoff.

The most common adverse reactions (reported in at least 20% of patients) were fatigue, musculoskeletal pain, nausea, and decreased appetite. Fourteen patients died from causes other than disease progression, including four patients who died from pneumonitis or cardiovascular failure attributed to nivolumab. 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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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