Opdivo

Chemical Namenivolumab
Dosage FormInjection (intravenous; 40 mg/4 mL, 100 mg/10 mL, 240 mg/24 mL)
Drug ClassMonoclonal antibodies
SystemRespiratory, Skin, Blood, Digestive, Urinary
CompanyBristol-Myers Squibb
Approval Year2014

Indication

  • For the treatment of unresectable or metastatic melanoma as a single agent or in combination with ipilimumab.
  • For the treatment of melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting.
  • For the treatment of Non-Small Cell Lung Cancer (NSCLC) in adult patients expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab.
  • For the treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy.
  • For the treatment of metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy.
  • For the treatment of unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab.
  • Used as a first-line treatment in combination with ipilimumab in patients with intermediate or poor risk advanced renal cell carcinoma.
  • Used as a first-line treatment in combination with cabozantinib in patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib.
  • For the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
  • For the treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after an autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT.
  • For the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.
  • For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • For the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab.
  • For the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib, as a single agent or in combination with ipilimumab.
  • For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.
Last updated on 4/19/2021

More on this drug: Clinical Trials

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Document TitleYearSource
Opdivo (nivolumab) Prescribing Information2020Bristol-Myers Squibb Company, Princeton, NJ