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    Drugs in Perspective: Opdivo (nivolumab)


    Melanoma is a form of cancer in melanocytes that may begin in a mole (skin melanoma) but can also begin in other pigmented tissues in the eyes or intestines. Approximately 76,100 new cases of melanoma and 9710 deaths from melanoma were anticipated in the United States in 2014.1 Melanoma is more common in men than women, among individuals of fair complexion, and those who have had excessive exposure to natural or artificial sunlight (such as tanning beds). Survival rates vary greatly based on stage at diagnosis. Five-year relative survival is 98% for patients diagnosed with localized disease, but only 16% for patients with metastatic disease at diagnosis.2 Until recently, pharmacologic options for advanced melanoma were very limited.1

    On December 22, 2014, Opdivo (nivolumab) was approved by FDA with a breakthrough therapy designation. Nivolumab is the second human programmed death-1 (PD-1) receptor-blocking antibody to gain accelerated approval for treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is based on tumor response rate and durability of response. Continued approval of nivolumab for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.3

    Related: BLOG: Promising late-stage melanoma pipeline to evolve treatment algorithm

    Nivolumab is available through specialty wholesalers as single-use vials containing 40 mg/4 mL or 100 mg/10 mL solution. Nivolumab requires dilution to its final infusion concentration. Additionally, special storage conditions are required due to lack of a preservative.3

    Nivolumab is administered as a 3 mg/kg intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Nivolumab should be withheld or discontinued in patients with select immune-mediated adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4). Nivolumab may be resumed in patients whose adverse reactions recover to grade 0 to 1.3

    Table 1: Nivolumab dose modifications

    Immune-mediated AE

    Withhold nivolumab

    Permanently discontinue nivolumab


    Grade 2

    Grade 3 or 4


    Grade 2 or 3

    Grade 4


    AST and ALT

    >3 to 5 times ULN

    >5 times ULN


    >1.5 to 3 times ULN

    >3 times ULN

    Nephritis and renal dysfunction


    1.5 to 6 times ULN

    >6 times ULN

    Hypothyroidism and hyperthyroidism

    No adjustment required

    No adjustment required

    Abbreviations: AE, adverse effect; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal.

    Source: Ref 3


    NEXT: Nivolumab studies


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