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Company: Bristol-Myers Squibb
Approval Status: FDA Approved December 2014
Specific Treatments: unresectable or metastatic melanoma
Drug: Nivolumab



Opdivo (nivolumab) is a human monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production.

Opdivo is specifically indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Opdivo is supplied as a solution for intravenous administration. The recommended dose of Opdivo is 3 mg/kg administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.



FDA Approval

Opdivo was approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The FDA approval of Opdivo for melanoma was based on a multicenter, open-label trial that randomized patients with unresectable or metastatic melanoma to receive either Opdivo administered intravenously at 3 mg/kg every 2 weeks or investigator’s choice of chemotherapy, either single-agent dacarbazine 1000 mg/m2 every 3 weeks or the combination of carboplatin AUC 6 every 3 weeks plus paclitaxel 175 mg/m2 every 3 weeks. Patients were required to have progression of disease on or following ipilimumab treatment and, if BRAF V600 mutation positive, a BRAF inhibitor. Tumor assessments were conducted 9 weeks after randomization then every 6 weeks for the first year, and every 12 weeks thereafter. Efficacy was evaluated in a single-arm, non-comparative, planned interim analysis of the first 120 patients who received Opdivo and in whom the minimum duration of follow up was 6 months. The major efficacy outcome measures in this population were confirmed objective response rate (ORR) as measured by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and duration of response. The ORR was 32%, consisting of 4 complete responses and 34 partial responses in Opdivo-treated patients. Of 38 patients with responses, 33 (87%) had ongoing responses with durations ranging from 2.6+ to 10+ months, which included 13 patients with ongoing responses of 6 months or longer. There were  objective responses in patients with and without BRAF V600 mutation positive melanoma.



The most common adverse reaction associated with the use of Opdivo was rash.



Opdivo (nivolumab)  is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. 

Source: centerwatch