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.
UT MD Anderson Cancer Center, Houston, Texas, United States
Northwestern University, Chicago, Illinois, United States
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Johns Hopkins, Baltimore, Maryland, United States
US Oncology and Hematology, Albany, New York, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Rockville Centre, Rockville Centre, New York, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Moffitt Cancer Center, Tampa, Florida, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Weill Cornell Medicine, New York, New York, United States
Sheba Medical Center, Ramat Gan, Israel
Royal Hobart Hospital, Hobart, Tasmania, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
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