Nivolumab (Opdivo)
General information
Class/mechanism: PD-1 receptor antibody. Nivolumab is an IgG4 kappa human monoclonal antibody which binds to the PD-1 (programmed death receptor-1) receptor and blocks its interaction with the ligands PD-L1 and PD-L2. Normally, PD-L1 and PD-L2 binding to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production, which can impede immune system surveillance of tumors. By interfering with the binding of PD-L1 and PD-L2 to the PD-1 receptor, nivolumab can cause upregulation of the anti-tumor immune response.[1][2][3]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 12/22/2014: FDA approved "for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor."
- 3/4/2015: FDA approved "for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy."
- 9/30/2015: Granted FDA accelerated approval "in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.
- 10/9/2015: FDA approval expanded "for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo."
- 11/23/2015: FDA approval expanded "for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy."
- 5/17/2016: FDA approval expanded "for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris)."
- 9/13/2016: FDA dosing recommendation changed to "240 mg IV every two weeks until disease progression or intolerable toxicity for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. When combined with ipilimumab for melanoma, after completion of ipilimumab, the recommended nivolumab dose will be 240 mg every two weeks until disease progression or intolerable toxicity."
Also known as
BMS-936558, MDX-1106.