Nivolumab (Opdivo)

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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]

Toxicity management

Diseases for which it is established (work in progress)

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

Bladder cancer

Colorectal cancer

Esophageal cancer

  • 6/10/2020: for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (New disease entity; based on ATTRACTION-3)
  • 4/16/2021: Approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (Based on CheckMate 649)
  • 5/20/2021: Approved for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. (Based on CheckMate 577)

Gastric cancer

  • 4/16/2021: Approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (Based on CheckMate 649)

Head and neck cancer

Hepatocellular carcinoma - PARTIALLY WITHDRAWN

  • 9/22/2017: Granted FDA accelerated approval for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. (New disease entity; based on CheckMate 040 cohorts 1 & 2)
    • 7/23/2021: Approval withdrawn.
  • 3/10/2020: Accelerated approval in combination with ipilimumab for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. (Approval extended to combination therapy; based on CheckMate 040 cohort 4)

Hodgkin lymphoma

Malignant pleural mesothelioma

  • 10/2/2020: Approved in combination with ipilimumab as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. (New disease entity; based on CheckMate 743)

Melanoma

Non-small cell lung cancer

  • 3/4/2015: Approved for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. (New disease entity; based on CheckMate 017)
  • 10/9/2015: Approval expanded for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. (Histology indication expanded to include nonsquamous; based on CheckMate 057)
    • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.
  • 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.
  • 5/15/2020: Approved in combination with ipilimumab as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1 (≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (Expanded to first-line setting, with PD-L1 expression requirement; based on CheckMate 227)
  • 5/26/2020: Approved in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (PD-L1 expression requirement removed when given with chemotherapy; based on CheckMate 9LA)
  • 3/4/2022: Approved with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. (Based on CheckMate 816)

Renal cell carcinoma

Small cell lung cancer - WITHDRAWN

History of changes in EMA indication

  • 6/19/2015: Initial marketing authorization as Opdivo.

Also known as

  • Code names: BMS-936558, MDX-1106, ONO-4538
  • Brand name: Opdivo

References