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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list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
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 ...
Ipilimumab was approved by the U.S. Food and Drug Administration (FDA) in March 2011, to treat people with late-stage melanoma that has spread or cannot be removed by surgery. [8] [11] [20] [21] [22] It was later approved by the US FDA on October 28, 2015, for stage 3 patients as adjuvant therapy. [23]
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 ...
It was approved in 2014. Nivolumab is approved to treat melanoma, lung cancer, kidney cancer, bladder cancer, head and neck cancer, and Hodgkin's lymphoma. [160] A 2016 clinical trial for non-small cell lung cancer failed to meet its primary endpoint for treatment in the first-line setting, but is FDA-approved in subsequent lines of therapy. [161]
The cohort used for the approved indication was conducted at 40 sites in 7 countries in North America and Europe. [37] In 2022, an early clinical study of dostarlimab reported a 100% remission rate in 14 patients with rectal cancer who had mismatch repair deficiency, a type of genetic mutation that only affects 5-10% of cases. [38] [39] [40]
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