Drug updated on 4/17/2024
| 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.
Summary
- Nivolumab (Opdivo) is indicated for the treatment of various types of cancers including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, and others. Its effectiveness varies across different types of cancers and specific patient groups.
- The information provided is based on a review of 64 systematic reviews/meta-analyses focused on nivolumab's use in treating these conditions.
- In terms of renal cell carcinoma (RCC), pembrolizumab shows a more significant disease-free survival advantage compared to placebo and the combination of nivolumab and ipilimumab following nephrectomy. However, overall survival rates did not significantly differ among the drugs studied.
- For non-small cell lung cancer (NSCLC), combining nivolumab with ipilimumab or chemotherapy particularly benefits patients with KRAS mutations by improving their overall survival rate as well as progression-free survival rate.
- When used in combination with ipilimumab for the first-line treatment against malignant pleural mesothelioma, it has shown promising results indicating its potential application for this condition.
- Nivolumab also demonstrates improved outcomes when combined with cabozantinib or ipilimumab as a first-line treatment against advanced renal cell carcinoma post anti-angiogenic therapy failure.
- In cases where classical Hodgkin Lymphoma has relapsed or progressed after autologous hematopoietic stem-cell transplantation (HSCT) and brentuximab vedotin treatments, Nivolumab provides an added benefit to patient survivability.
- Nivolumab improves outcomes both during adjuvant settings for high-risk patients after radical resectioning and for locally advanced/metastatic urothelial carcinomas that have failed platinum-containing chemotherapy treatments.
- The drug showed efficacy in microsatellite instability-high (MSI-H)/ mismatch repair deficient (dMMR) colorectal cancer patients after standard treatments failed, emphasizing its role in MSI-H/dMMR conditions.
- Nivolumab's safety profile shows a higher incidence of adverse events compared to placebo when used for the treatment of RCC post-nephrectomy. This suggests that careful consideration is needed due to potential side effects.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Opdivo (nivolumab) prescribing information. | 2024 | Bristol-Myers Squibb Company, Princeton, NJ |