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 7/12/2022

More on this drug: Clinical Trials

Have we missed a study, or would you like to comment on a study?

Document TitleYearSource
Opdivo (nivolumab) Prescribing Information.2022Bristol-Myers Squibb Company, Princeton, NJ
Document TitleYearSource
Nivolumab with ipilimumab for untreated advanced renal cell carcinoma. 2022NICE
Assessment report: Yervoy and Opdivo. 2022EMA
Assesment report: Opdivo. 2022EMA
Nivolumab for previously treated unresectable advanced or recurrent oesophageal cancer. 2021NICE
Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease. 2021NICE
Nivolumab with ipilimumab and chemotherapy for untreated metastatic non-small-cell lung cancer. 2021NICE
Nivolumab for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy. 2021NICE
Australian public assessment report for nivolumab and ipilimumab.2021Australian Government: Department of Health
Nivolumab with ipilimumab for previously treated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency.2021NICE
Clinical and pharmacoeconomic combined report: nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for malignant pleural mesothelioma. 2021CADTH
Final clinical guidance report: nivolumab (Opdivo) with ipilimumab (Yervoy) for non-small cell lung cancer.2021CADTH
Final clinical economic report: nivolumab (Opdivo) with ipilimumab (Yervoy) for non-small cell lung cancer.2021CADTH
Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy.2020NICE
Australian public assessment report for nivolumab. 2020Australian Government: Department of Health
Nivolumab with ipilimumab for untreated advanced renal cell carcinoma.2019NICE
Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease.2019NICE
Final economic guidance report: nivolumab (Opdivo) for adjuvant melanoma.2019CADTH
Final clinical guidance report: nivolumab (Opdivo) for adjuvant melanoma.2019CADTH
Nivolumab for treating locally advanced unresectable or metastatic urothelial cancer after platinum-containing chemotherapy.2018NICE
Final economic guidance report: nivolumab (Opdivo) for hepatocellular carcinoma.2018CADTH
Final clinical guidance report: nivolumab (Opdivo) for hepatocellular carcinoma.2018CADTH
Final economic guidance report: nivolumab (Opdivo) for classical Hodgkin lymphoma. 2018CADTH
Final clinical guidance report: nivolumab (Opdivo) for classical Hodgkin lymphoma.2018CADTH
Final clinical report: nivolumab (Opdivo) with ipilimumab (Yervoy) for renal cell carcinoma.2018CADTH
Final economic report: nivolumab (Opdivo) with ipilimumab (Yervoy) for renal cell carcinoma.2018CADTH
Nivolumab for treating squamous cell carcinoma of the head and neck after platinum-based chemotherapy.2017NICE
Nivolumab for treating relapsed or refractory classical Hodgkin lymphoma.2017NICE
Final clinical guidance report: nivolumab (Opdivo) with ipilimumab (Yervoy) for metastatic melanoma. 2017CADTH
Final economic guidance report: nivolumab (Opdivo) with ipilimumab (Yervoy) for metastatic melanoma.2017CADTH
Nivolumab for treating squamous cell carcinoma of the head and neck after platinum-based chemotherapy.2017NICE
Final economic guidance report: nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease.2017CADTH
Final clinical guidance report: nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease.2017CADTH
Document TitleYearSource
Neoadjuvant immunotherapy prior to surgery for mucosal head and neck squamous cell carcinoma: systematic review.2022Head & Neck
First-line treatments for extensive-stage small-cell lung cancer with immune checkpoint inhibitors plus chemotherapy: a network meta-analysis and cost-effectiveness analysis.2022Frontiers in Oncology
The efficacy and safety of combined ipilimumab and nivolumab versus ipilimumab in patients with stage III/IV unresectable melanoma: a systematic review and meta‑analysis.2022Journal of Cancer Research and Therapeutics
Autoimmune retinopathy with associated anti-retinal antibodies as a potential immune-related adverse event associated with immunotherapy in patients with advanced cutaneous melanoma: case series and systematic review. 2022BMJ Open Ophthalmology
Selection of optimal first-line immuno-related therapy based on specific pathological characteristics for patients with advanced driver-gene wild-type non-small cell lung cancer: a systematic review and network meta-analysis.2021Therapeutic Advances in Medical Oncology
Prevalence of dermatological toxicities in patients with melanoma undergoing immunotherapy: systematic review and meta-analysis.2021PLoS One
Chemotherapy in focus: a meta-analysis confronts immunotherapy in the treatment of advanced melanoma.2021Critical Reviews in Oncology/Hematology
Systematic review and meta‑analysis efficacy and safety of immune checkpoint inhibitors in advanced melanoma patients with anti‑PD‑1 progression: a systematic review and meta‑analysis.2021Clinical & Translational Oncology
Single or combined immune checkpoint inhibitors compared to first‐line platinum‐based chemotherapy with or without bevacizumab for people with advanced non‐small cell lung cancer.2021Cochrane Database of Systematic Reviews
Nivolumab for adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer.2021NICE
Nivolumab plus ipilimumab versus existing immunotherapies in patients with PD-L1-positive advanced non-small cell lung cancer: a systematic review and network meta-analysis.2020Cancers
Potential immune-related adverse events associated with monotherapy and combination therapy of ipilimumab, nivolumab, and pembrolizumab for advanced melanoma: a systematic review and meta-analysis.2020Frontiers in Oncology
Immune checkpoint inhibitors in advanced acral melanoma: a systematic review.2020Frontiers in Oncology
First-line treatments for advanced renal cell carcinoma with immune checkpoint inhibitors: systematic review, network meta-analysis and cost-effectiveness analysis.2020Therapeutic Advances in Medical Oncology
Economic evaluation of systemic treatments for advanced melanoma: a systematic review.2020Value in Health
Immune checkpoint inhibitors and immune-related adverse events in patients with advanced melanoma.2020JAMA Network Open
Targeted therapy for metastatic renal cell carcinoma.2020Cochrane Database of Systematic Reviews
Role of immune checkpoint inhibitor-based therapies for metastatic renal cell carcinoma in the first-line setting: a Bayesian network analysis. 2019EBioMedicine
The differences in the safety and tolerability of immune checkpoint inhibitors as treatment for non–small cell lung cancer and melanoma: network meta-analysis and systematic review.2019Frontiers in Pharmacology
Nivolumab for adults with Hodgkin's lymphoma (a rapid review using the software RobotReviewer).2018Cochrane Database of Systematic Reviews
Immune-related adverse events for anti-PD-1 and anti-PD-L1 drugs: systematic review and meta-analysis.2018BMJ
Comparative safety of immune checkpoint inhibitors in cancer: systematic review and network meta-analysis.2018BMJ
Risk of immune-related pancreatitis in patients with solid tumors treated with immune checkpoint inhibitors: systematic assessment with meta-analysis.2018Journal of Immunology Research
Gastrointestinal adverse events with combination of checkpoint inhibitors in advanced melanoma: a systematic review.2018Melanoma Management
Cabozantinib versus everolimus, nivolumab, axitinib, sorafenib and best supportive care: a network meta-analysis of progression-free survival and overall survival in second line treatment of advanced renal cell carcinoma.2017PLoS One
Efficacy and safety of anti-PD-1 and anti-PD-1 combined with anti-CTLA-4 immunotherapy to advanced melanoma: a systematic review and meta-analysis of randomized controlled trials.2017Medicine
Multiple treatment comparison of seven new drugs for patients with advanced malignant melanoma: a systematic review and health economic decision model in a Norwegian setting.2017BMJ Open
Immune checkpoint blockade for unresectable or metastatic uveal melanoma: a systematic review.2017Cancer Treatment Reviews
Treatment-related death in cancer patients treated with immune checkpoint inhibitors: a systematic review and meta-analysis.2017Clinical Oncology
Immune-related ocular toxicities in solid tumor patients treated with immune checkpoint inhibitors: a systematic review.2017Expert Review of Anticancer Therapy
Risk of treatment-related mortality in cancer patients treated with ipilimumab: a systematic review and meta-analysis.2017European Journal of Cancer
Checkpoint inhibitors for malignant melanoma: a systematic review and meta-analysis.2017Clinical, Cosmetic and Investigational Dermatology
Efficacy and safety of anti-PD-1 and anti-PD-1 combined with anti-CTLA-4 immunotherapy to advanced melanoma: a systematic review and meta-analysis of randomized controlled trials.2017Medicine
Immunotherapy for metastatic renal cell carcinoma.2017Cochrane Database of Systematic Reviews
Document TitleYearSource
Systemic therapy in metastatic renal cell carcinoma (mRCC): an evidence‑based recommendation of the German interdisciplinary RCC guidelines group.2022World Journal of Urology
Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update.2021Journal of Clinical Oncology
SEOM clinical guideline for the management of cutaneous melanoma (2020).2021Clinical & Translational Oncology
ESMO clinical practice guideline update on the use of immunotherapy in early stage and advanced renal cell carcinoma. 2021Annals of Oncology
Systemic therapy for melanoma: ASCO guideline.2020Journal of Clinical Oncology
Systemic therapy for advanced hepatocellular carcinoma: ASCO guideline.2020Journal of Clinical Oncology
Argentinian clinical practice guideline for surveillance, diagnosis, staging and treatment of hepatocellular carcinoma.2020Annals of Hepatology
Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology clinical practice guideline update.2020Journal of Clinical Oncology
SEOM clinical guideline for treatment of kidney cancer (2019).2020Clinical & Translational Oncology
Systemic adjuvant therapy for adult patients at high risk for recurrent cutaneous or mucosal melanoma: an Ontario Health (Cancer Care Ontario) clinical practice guideline.2020Current Oncology
Cutaneous melanoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up.2019Annals of Oncology
An update on the Society for Immunotherapy of Cancer consensus statement on tumor immunotherapy for the treatment of cutaneous melanoma: version 2.0.2018Journal for the ImmunoTherapy of Cancer