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.
Massachusetts General Hospital, Boston, Massachusetts, United States
UCSD, San Diego, California, United States
UCLA, Santa Monica, California, United States
Local Institution - 350, Boston, Massachusetts, United States
University Hospital Zurich, Zurich, Switzerland
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
Clinica Universidad de Navarra, Pamplona, Spain
Centre Hospitalier Lyon Sud, Pierre Benite, France
H. C. U. de Valladolid, Valladolid, Spain
H. U. Virgen de la Victoria, Malaga, Spain
Hospital La Paz, Madrid, Spain
Dutch Cancer Institute/ A v. Leeuwenhoek Hospital, Amsterdam, Netherlands
University Medical Center Groningen, Groningen, Netherlands
Erasmus Medical Center, Rotterdam, Netherlands
Johns Hopkins University School Of Medicine, Baltimore, Maryland, United States
Local Institution - 0090, Chattanooga, Tennessee, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Bay Hematology Oncology, Easton, Maryland, United States
Southern Cancer Center, Mobile, Alabama, United States
Virginia Cancer Specialists (Leesburg) - USOR, Leesburg, Virginia, United States
Local Institution - 0051, Beijing, Beijing, China
Local Institution - 0007, Beijing, Beijing, China
Local Institution - 0039, Chelyabinsk, Russian Federation
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
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