Opdivo (nivolumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved November 2015

Specific Treatments:

advanced renal cell carcinoma

Therapeutic Areas

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General Information

Opdivo (nivolumab) targets the cellular pathway known as PD-1/PD-L1, proteins found on the body’s immune cells and some cancer cells. By blocking this pathway, Opdivo may help the body’s immune system fight cancer cells.

Opdivo is specifically indicated for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

Opdivo is supplied as a solution for intravenous infusion. The recommended dose of Opdivo is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Clinical Results

FDA Approval

The FDA approval of Opdivo for renal cell carcinoma was based on an open-label, randomized study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agent. Patients were treated with Opdivo or another type of kidney cancer treatment called everolimus (marketed as Afinitor). Those treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with Afinitor. This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors. Additionally, 21.5 percent of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to 3.9 percent of those taking Afinitor, lasting an average of 13.7 months.

Side Effects

Adverse effects associated with the use of Opdivo may include, but are not limited to, the following:

  • abnormal weakness or lack of energy (asthenic conditions)
  • cough
  • nausea
  • rash
  • dyspnea
  • diarrhea
  • constipation
  • decreased appetite
  • back pain
  • arthralgia

Opdivo also has the potential to cause serious side effects that result from the immune system effect of Opdivo (known as “immune-mediated side effects”). 

Mechanism of Action

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. 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. 

Additional Information

For additional information regarding Opdivo or advanced renal cell carcinoma, please visit http://www.opdivo.bmscustomerconnect.com/gateway