Nivolumab Injection, API Form : Liquid

A drug that binds to the protein PD-1 to help immune cells kill cancer cells better and is used to treat many different types of cancer. These include cancers that express the protein PD-L1 or that have certain mutations (changes) in genes involved in DNA repair. Nivolumab is used alone or with other drugs to treat certain types of esophageal cancer, gastroesophageal junction cancer, stomach cancer, colorectal cancer, non-small cell lung cancer, renal cell carcinoma (a type of kidney cancer), melanoma, hepatocellular carcinoma (a type of liver cancer), squamous cell carcinoma of the head and neck, classic Hodgkin lymphoma, urothelial carcinoma (a type of bladder or urinary tract cancer), and malignant pleural mesothelioma. It is also being studied in the treatment of other types of cancer. Nivolumab may block PD-1 and help the immune system kill cancer cells. It is a type of monoclonal antibody and a type of immune checkpoint inhibitor. Also called Opdivo.

Nivolumab is approved to be used alone or with other drugs to treat:

• Classic Hodgkin lymphoma
• Colorectal cancer
• Esophageal cancer or gastroesophageal junction adenocarcinoma.
• Gastric (stomach) cancer, gastroesophageal junction adenocarcinoma, or esophageal cancer
• Malignant pleural mesothelioma.
• Melanoma
• Non-small cell lung cancer.
• Renal cell carcinoma
• Squamous cell carcinoma of the head and neck
• Urothelial carcinoma

Nivolumab was approved for medical use in the United States in 2014. It is 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.

The combination of nivolumab with ipilimumab is used for the first-line treatment of adults with malignant pleural mesothelioma (MPM) that cannot be removed by surgery.

In April 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab, in combination with certain types of chemotherapy, for the initial treatment of people with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

In May 2021, the U.S. FDA approved nivolumab for people with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.[8]

In August 2021, the U.S. FDA approved nivolumab for the adjuvant treatment of people with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection.[16]

In May 2022, the U.S. FDA expanded the indication to include the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC).