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Opdivo Approved for Urothelial Carcinoma

FDA news release; 2017 Feb 2

The FDA granted accelerated approval to nivolumab (Opdivo) for treatment of patients with locally advanced or metastatic urothelial carcinoma.

Indications: Opdivo is a programmed death receptor-1 blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • Have disease progression during or following platinum-containing chemotherapy.
  • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Dosage and administration: 240 mg every 2 weeks.

Efficacy and safety: Accelerated approval is based on a single-arm study involving 270 individuals that showed objective response rate of 19.6%. 7 patients had complete response and 46 partial response.

Side effects/risks: The most common adverse reactions were fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, and pyrexia.


Nivolumab for Treatment of Urothelial Carcinoma [news release]. Silver Spring, MD: FDA February 2, 2017. Accessed February 4, 2017.

Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 2017. Accessed February 4, 2017.