Drug updated on 9/4/2024
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
Summary
- Opdivo (nivolumab) is indicated for the treatment of various cancers in adults and pediatric patients 12 years and older, including melanoma, non-small cell lung cancer, and renal cell carcinoma, either alone or in combination with other therapies. It is also used for the treatment of unresectable malignant pleural mesothelioma, advanced or metastatic esophageal and gastric cancers, and urothelial carcinoma, among others. Additionally, Opdivo is approved for use in patients with classical Hodgkin lymphoma, hepatocellular carcinoma, and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer.
- This summary is based on the review of 61 systematic review(s)/meta-analysis(es). [1-61]
- Disease-Free Survival (DFS): Pembrolizumab was effective in enhancing DFS among Renal Cell Carcinoma (RCC) patients post-nephrectomy compared to placebo (HR = 0.83, 95% CI 0.70 to 0.99). Nivolumab plus ipilimumab did not significantly improve DFS in RCC patients.
- Overall Survival (OS): Nivolumab as a second-line treatment improved OS in Non-Small Cell Lung Cancer (NSCLC) patients with KRAS mutations. For advanced NSCLC, nivolumab plus ipilimumab showed a 3-year OS rate of 35% and a median OS of 18.6 months. In Oesophageal Squamous Cell Carcinoma (OSCC), nivolumab had a relatively lower incidence of treatment-related adverse events but was less effective in OS compared to pembrolizumab.
- Progression-Free Survival (PFS): In NSCLC with KRAS mutations, nivolumab was more effective as a second-line treatment for PFS. In advanced NSCLC, nivolumab plus ipilimumab showed good PFS and Objective Response Rate (ORR) in PD-L1 non-selective populations, particularly for PD-L1-negative patients. Atezo-bev-chemo significantly prolonged PFS in patients with PD-L1 TPS ≥50%.
- Objective Response Rate (ORR): Pembrolizumab combined with chemotherapy showed the highest ORR in Head and Neck Cancer. Nivolumab demonstrated high ORR in Melanoma both as a monotherapy and in combination with ipilimumab.
- Nivolumab plus ipilimumab showed the highest risk for all-grade and grade 3-4 pulmonary adverse events (PAEs) among immune checkpoint inhibitor (ICI) combinations.
- Dual ICI therapies (nivolumab plus ipilimumab) generally demonstrated higher rates of severe adverse events (AEs) compared to monotherapies, particularly in melanoma and advanced NSCLC.
- Combination therapy of nivolumab plus ipilimumab was associated with a higher risk of severe dermatologic immune-related adverse events (irAEs) compared to monotherapies.
- Nivolumab combined with chemotherapy in advanced NSCLC showed a higher incidence of grade ≥3 AEs compared to nivolumab monotherapy.
- In Non-Small Cell Lung Cancer (NSCLC), nivolumab was found to be effective as a second-line treatment in patients with KRAS mutations, while pembrolizumab was more effective as a first-line treatment. Additionally, nivolumab plus ipilimumab demonstrated effectiveness across various PD-L1 expression levels, with significant efficacy noted in PD-L1-negative patients.
- In Glioblastoma, high levels of the p-ERK biomarker were associated with prolonged overall survival (OS) when treated with a combination of nivolumab and ipilimumab.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Opdivo (nivolumab) prescribing information. | 2024 | Bristol-Myers Squibb Company, Princeton, NJ |