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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.

Citation:

Nivolumab for Treatment of Urothelial Carcinoma [news release]. Silver Spring, MD: FDA February 2, 2017. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm. Accessed February 4, 2017.

Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 2017. http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s024lbl.pdf. Accessed February 4, 2017.