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.
Local Institution - 0001, Berlin, Germany
Local Institution - 0002, Sevilla, Spain
Local Institution - 0020, Essen, North Rhine-Westphalia, Germany
Erasmus MC, Rotterdam, Netherlands
China Medical University Hospital, Taichung, Please Select, Taiwan
Weill Cornell Medicine/New York-Presbyterian, New York, New York, United States
Lifespan Cancer Institute, Providence, Rhode Island, United States
CHU d'Estaing, Clermont-Ferrand, France
Institut Andrée Dutreix - Clinique de Flandre, Coudekerque-Branche, France
Clinique de l'Europe, Amiens, France
Queen Mary Hospital, Hong Kong, Hong Kong
University of Michigan, Ann Arbor, Michigan, United States
University of Alabama at Birmingham, Birmingham, Alabama, United States
Rady Children's Hospital/University of California, San Diego, San Diego, California, United States
Zealand University Hospital, Roskilde, Denmark
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
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