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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The first FDA-approved therapeutic monoclonal antibody was a murine IgG2a CD3 specific transplant rejection drug, OKT3 (also called muromonab), in 1986. This drug found use in solid organ transplant recipients who became steroid resistant. [39] Hundreds of therapies are undergoing clinical trials. Most are concerned with immunological and ...
Muromonab-CD3 was approved by the U.S. Food and Drug Administration (FDA) in 1986, [5] making it the first monoclonal antibody to be approved anywhere as a drug for humans. In the European Communities , it is the first drug to be approved under the directive 87/22/EWG, a precursor of the European Medicines Agency (EMA) centralised approval ...
Monoclonal antibodies for cancer. ADEPT, antibody directed enzyme prodrug therapy; ADCC: antibody dependent cell-mediated cytotoxicity; CDC: complement-dependent cytotoxicity; MAb: monoclonal antibody; scFv, single-chain Fv fragment. [44] MAbs approved by the FDA for cancer include: [45]
They started the field of monoclonal antibody development and won the Nobel Prize for Medicine in 1984 for their work. [13] Soon after, muromonab-CD3 became the first fully licensed monoclonal antibody in 1986 for its use in treating kidney transplant rejection. [14] Since then, over 70 monoclonal antibodies have been approved by the FDA. [15]
The principle of monoclonal antibody production, called hybridoma technology, was published in 1975 by Georges Köhler and César Milstein, [30] who were awarded the 1984 Medicine Nobel Prize for their discovery together with Niels Kaj Jerne. [31] Muromonab-CD3 was the first monoclonal antibody to be approved for clinical use in humans, in 1986 ...
Retifanlimab (Zynyz) was developed by Incyte and first granted accelerated approval by the FDA in March 2023 for the treatment of Merkel cell carcinoma (MCC). Toripalimab (Loqtorzi) is a humanized IgG4 monoclonal antibody against PD-1 approved in China in 2018 and in the United States in 2023. [18] [19] [20]
Eculizumab, sold under the brand name Soliris among others, is a recombinant humanized monoclonal antibody used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica.