Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication in the class of immune checkpoint inhibitors. It selectively binds and blocks the programmed death-1 (PD-1) receptor on T cells, thereby facilitating their activation. It is used to treat certain types of cancer including melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction cancer. It is administered intravenously. The most common side effects include fatigue, rash, musculoskeletal pain, pruritus (itching), diarrhea, nausea, asthenia (weakness), cough, dyspnea (shortness of breath), constipation, decreased appetite, back pain, arthralgia (joint pain), upper respiratory tract infection, pyrexia (fever), headache, abdominal pain, and vomiting. Use during pregnancy may harm the baby. Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. The most common side effects when used in combination with chemotherapy include peripheral neuropathy (damage to the nerves outside of the brain and spinal cord), nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain. Nivolumab was approved for medical use in the United States in 2014. Nivolumab is a therapeutic alternative on the World Health Organization's List of Essential Medicines. It is made using Chinese hamster ovary cells. Nivolumab is the second FDA-approved systemic therapy for mesothelioma and is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.
Medical uses In the US, nivolumab is indicated to treat:
Nivolumab is used as a first-line treatment for inoperable or metastatic melanoma in combination with ipilimumab if the cancer does not have a mutation in BRAF. It is also used as a second-line treatment for inoperable or metastatic melanoma following treatment with ipilimumab and, if the cancer has a BRAF mutation, a BRAF inhibitor. It is also used to treat metastatic squamous non-small cell lung cancer with progression with or after platinum-based drugs, and for treatment of small cell lung cancer. It is also used as a second-line treatment for renal cell carcinoma after anti-angiogenic treatment has failed. Nivolumab is used for primary or metastatic urothelial carcinoma, the most common form of bladder cancer. It can be used for locally advanced or metastatic disease that progresses during or following platinum-based chemotherapy or progresses within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. Nivolumab is indicated for the adjuvant treatment of melanoma with lymph node involvement as well as in metastatic disease with previous complete resection. The combination of nivolumab with ipilimumab is used for the first-line treatment of adults with inoperable malignant pleural mesothelioma. In April 2021, the US Food and Drug Administration (FDA) approved nivolumab, in combination with certain types of chemotherapy, for the initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. In May 2021, the FDA approved nivolumab for the treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease after neoadjuvant chemoradiotherapy. In August 2021, the FDA approved nivolumab for the adjuvant treatment of urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. In May 2022, the FDA expanded the indication to include the first-line treatment of people with advanced or metastatic esophageal squamous cell carcinoma. In the same year, the FDA approved a combination therapy consisting of relatlimab and nivolumab for the treatment of some cases of advanced melanoma. In March 2024, the FDA approved nivolumab, in combination with cisplatin and gemcitabine, as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. In October 2024, the FDA approved nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In April 2025, the FDA approved Nivolumab with Ipilimumab (Yervoy, Bristol Myers Squibb) for the treatment of adults and children aged 12 years and older with certain types of colorectal cancer.
Side effects The US FDA prescription label contains warnings regarding increased risk for severe immune-mediated inflammation of the lungs, colon, liver, and kidneys (with accompanying kidney dysfunction), as well as immune-mediated hypothyroidism and hyperthyroidism. Hypothyroidism and hyperthyroidism may affect 8.5% and 3.7% of patients, respectively. Autoimmune diabetes similar to diabetes mellitus type 1 may occur in approximately 2% of people treated with nivolumab. In trials for melanoma, the following side effects occurred in more than 10% of subjects and more often than with chemotherapy alone: rash and itchy skin, cough, upper respiratory tract infections, and peripheral edema. Other clinically important side effects with less than 10% frequency were ventricular arrhythmia, inflammation of parts of the eye (iridocyclitis), infusion-related reactions, dizziness, peripheral and sensory neuropathy, peeling skin, erythema multiforme, vitiligo, and psoriasis. In trials for lung cancer, the following side effects occurred in more than 10% of subjects and more often than with chemotherapy alone: fatigue, weakness, edema, fever, chest pain, generalized pain, shortness of breath, cough, muscle and joint pain, decreased appetite, abdominal pain, nausea and vomiting, constipation, weight loss, rash, and itchy skin. Levels of electrolytes and blood cells counts were also disrupted.
Pregnancy and breastfeeding Use during pregnancy may harm the baby.
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