Drug updated on 7/25/2024
Dosage Form | Injection (intravenous; 40 mg/4 mL, [10 mg/mL], 100 mg/10 mL, [10 mg/mL], 120 mg/12 mL [10 mg/mL], 240 mg/24 mL [10 mg/mL]) |
Drug Class | Programmed death receptor-1 (PD-1) blocking antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma as a single agent or in combination with ipilimumab.
- Indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
- Indicated for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.
- Indicated 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.
- Indicated for the treatment of metastatic or recurrent non-small cell lung cancer in adult patients with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy.
- Indicated for the treatment of adult patients with metastatic non-small cell lung cancer and 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.
- Indicated for the treatment of unresectable malignant pleural mesothelioma in adult patients, as first-line treatment in combination with ipilimumab.
- Indicated for use as a first-line treatment in combination with ipilimumab in adult patients with intermediate or poor risk advanced renal cell carcinoma.
- Indicated for use as a first-line treatment in combination with cabozantinib in adult patients with advanced renal cell carcinoma.
- Indicated for the treatment of adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
- Indicated 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.
- Indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.
- Indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
- Indicated 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.
- Indicated 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.
- Indicated for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib, as a single agent or in combination with ipilimumab.
- Indicated for the treatment ofadult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy.
- Indicated for the treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum containing chemotherapy.
- Indicated for the treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab.
- Indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
- Indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.
Latest News
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Summary
- Nivolumab (Opdivo) is indicated for the treatment of various cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), Hodgkin's lymphoma, hepatocellular carcinoma, head and neck cancer, urothelial carcinoma, and colorectal cancer with microsatellite instability-high or mismatch repair-deficient tumors.
- The total number of studies reviewed was 61 from systematic reviews and meta-analyses.
- For advanced melanoma in adults and pediatric patients aged 12 years and older, nivolumab as monotherapy or combined with ipilimumab shows significant benefits in overall response rates and survival durations compared to other treatments like pembrolizumab.
- In NSCLC patients expressing PD-L1 ≥1%, nivolumab combined with ipilimumab demonstrates notable efficacy. Specific regimens such as nivolumab plus ipilimumab plus chemotherapy are optimal for certain PD-L1 subgroups without EGFR or ALK genomic tumor aberrations.
- Combination therapies involving nivolumab show superior overall survival in RCC when used alongside agents like cabozantinib compared to sunitinib. Long-term benefits are particularly noted when combining it with ipilimumab for intermediate/poor risk advanced cases.
- Nivolumab provides promising outcomes post-autologous stem cell transplantation in adult patients with classical Hodgkin lymphoma that has relapsed after multiple lines of systemic therapy, including brentuximab vedotin.
- For previously treated hepatocellular carcinoma cases where sorafenib was administered earlier, combination therapy using nivolumab along with ipilimumab shows some promise according to studies reviewed.
- Patients suffering from recurrent/metastatic squamous cell carcinoma of the head and neck who progressed following platinum-based therapies benefit significantly more through standalone administration of Opdivo compared to combinations including additional immune checkpoint inhibitors.
- Adverse events primarily include severe grade three/four immune-related conditions such as colitis, hepatitis, and pneumonitis, especially prevalent when using dual-agent protocols featuring both ipilimumab and nivolumab rather than single-drug approaches.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Opdivo (nivolumab) prescribing information. | 2024 | Bristol-Myers Squibb Company, Princeton, NJ |