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Company: Bristol-Myers Squibb
Approval Status: FDA Approved March 2015
Specific Treatments: metastatic squamous non-small cell lung cancer
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 metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Opdivo is supplied as a solution for intravenous infusion. The recommended dose is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Please see the drug label for specific dose modifications.



FDA Approval

The FDA approved of Opdivo for metastatic squamous nonsmall cell lung cancer was based on a randomized, open-label study enrolling 272 patients with metastatic squamous NSCLC who had experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen. Patients received Opdivo administered intravenously at 3 mg/kg every 2 weeks or docetaxel administered intravenously at 75 mg/m2 every 3 weeks. This study included patients regardless of their PD-L1 status. The first tumor assessments were conducted 9 weeks after randomization and continued every 6 weeks thereafter. The major efficacy outcome measure was overall survival (OS). The trial demonstrated a statistically significant improvement in OS for patients randomized to Opdivo as compared with docetaxel at the prespecified interim analysis when 199 events were observed (86% of the planned number of events for final analysis). The median survival was 9.2 months versus 6.0 months for the Opdivo versus docetaxel arms, respectively.



Adverse effects associated with the use of Opdivo for advanced squamous non-small cell lung cancer may include, but are not limited to, the following:

  • fatigue
  • dyspnea
  • musculoskeletal pain
  • decreased appetite
  • cough
  • nausea
  • constipation 



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