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    Immunotherapy approved for advanced urothelial Ca

    The FDA has approved nivolumab (Opdivo) injection for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

    Also see: Urology FDA approvals of 2016

    Bristol-Myers Squibb said that the approval covers treatment of patients who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

    “Urologists are familiar with Opdivo as it was approved in 2015 for advanced renal cell carcinoma. The drug has indications in at least four other cancers including melanoma, lung cancer, head and neck cancers, and Hodgkin’s lymphoma,” Leonard G. Gomella, MD, of Jefferson Sidney Kimmel Cancer Center, Thomas Jefferson University, told Urology Times. “Other checkpoint inhibitors have also demonstrated utility in advanced urothelial carcinoma trials and are very likely to follow in this disease state.”

    Nivolumab is the second in class of immune checkpoint inhibitors approved for advanced bladder cancer. Tecentriq (atezolizumab) was the first PD-L1 checkpoint inhibitor approved by the FDA (in May 2016) for advanced urothelial carcinoma.

    The nivolumab approval came following positive results from CheckMate-275, a phase II, open-label, single-arm, multicenter study evaluating 270 patients with advanced or metastatic urothelial carcinoma. In that study, 19.6% of patients responded to treatment with nivolumab, consisting of 2.6% of patients with a complete response and 17% of patients with a partial response. Among responders, the median duration of response was 10.3 months and the median time to response was 1.9 months.

    The recommended dose for mUC is 240 mg, administered as an intravenous infusion over an hour every 2 weeks until disease progression or unacceptable toxicity.

    Next: FDA approval accelerated thanks to strong beneficial tumor response rate and duration observed in phase III clinical trial

    Keith Loria
    Keith Loria is a contributing writer to Medical Economics.


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