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.
NYU Langone Health, New York, New York, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
City of Hope National Medical Center, Duarte, California, United States
Exelixis Clinical Site #32, Pittsburgh, Pennsylvania, United States
Exelixis Clinical Site #24, Pittsburgh, Pennsylvania, United States
Exelixis Clinical Site #89, Dallas, Texas, United States
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
State University of Iowa, Iowa City, Iowa, United States
Columbia University Irving Medical Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
City of Hope Medical Center, Duarte, California, United States
University of California, San Diego, La Jolla, California, United States
Royal Brisbane and Womens hospital, Herston, Queensland, Australia
Sir Charles Gairdner, Nedlands, Western Australia, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Duke Univ. Medical Center, Durham, North Carolina, United States
Cancer Hematology Centers - Flint, Flint, Michigan, United States
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
National Taiwan University Hospital, Taipei, Taiwan
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