Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1). This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation S228P for additional stability and reduced variability. It was developed by Bristol Myers Squibb.
Nivolumab was granted FDA approval on 22 December 2014.
Nivolumab is indicated to treat unresectable or metastatic melanoma, melanoma as adjuvant treatment, resectable or metastatic non-small cell lung cancer, small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, hepatocellular carcinoma, and esophageal cancer. The indication for classical Hodgkin lymphoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and hepatocellular carcinoma were approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Nivolumab is also approved for the treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma when used in combination with a fluoropyrimidine- and platinum-containing chemotherapy regimen.
In combination with relatlimab, nivolumab is indicated for the treatment of patients ≥12 years old with unresectable or metastatic melanoma.
Boston Children's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Local Institution - 0010, Boston, Massachusetts, United States
Local Institution - 0001, Hackensack, New Jersey, United States
Local Institution - 0003, Houston, Texas, United States
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Universitätsklinikum Freiburg, Freiburg, Germany
University Medicine Greifswald, Greifswald, Germany
Universitätsklinikum Halle (Saale), Halle (Saale), Germany
Rambam MC, Haifa, Israel
City of Hope National Medical Center, Duarte, California, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
University of Miami, Miami, Florida, United States
MD Anderson Cancer Center, Houston, Texas, United States
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan
Prince Of Wales Hospital, Hong Kong, Hong Kong
Dalin Tzu Chi Hospital, Chiayi City, Taiwan
Royal Adelaide Hospital, Adelaide, South Australia, Australia
CHU de Reims-Hopital Robert Debre, Reims, France
The Chinese University of Hong Kong Prince of Wales Hospital, Shatin, Hong Kong
M D Anderson Cancer Center, Houston, Texas, United States
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