Monoclonal antibody approved

Joshi, A., Bauer, R., Kuebler, P, White, M., Leddy, C., Compton, P., Garovoy, M., Kwon, P., Walicke, P., and Dedrick, R. 2006. An overview of the pharmacokinetics and pharmacodynamics of efalizumab a monoclonal antibody approved for use in psoriasis. Journal of Clinical Pharmacology 46(1), 10-20. 

The three monoclonal antibodies approved, noted in Table 23.1, in the last 7 years for treatment of patients with cancer include Alemtuzumab (Campath M) (Genzyme Corporation, Cambridge, MA, U.S.A.), Cetuzimab (Erbitux ) (ImClone Corporation, Branchburg, NJ, U.S.A.), and bevacizumab (Avastin ) (Genentech, South San Francisco, CA, U.S.A.). 

Grillo-Lopez, A.J., White, C.A., Yarns, C., Shen, D., Wei, A., McClure, A., and Dallaire, B.K., Overview of the clinical development of Rituximab first monoclonal antibody approved for the treatment of Lymphoma, Semin. Oncol., 26(suppl. 14), 66-73, 1999. 

TABLE 4.3 Monoclonal Antibodies Approved for Cancer Treatment... 

Muromonab (Orthoclone OKT3 ) is a mouse monoclonal antibody that kills T lymphocytes, cells that are a part of the immune response. Muromonab, the first monoclonal antibody approved for use as a drug, is used to treat rejection of a donated kidney, liver, or... 

Although Epstein-Barr virus (EBV) is capable of inducing cellular transformation, few antibody-producing B lymphocytes display the viral cell surface receptor. Most, therefore, are immune to EBV infection. Even upon successful transformation, most produce low-affinity IgM antibodies, and the cells are often unstable. Having said that, one monoclonal antibody approved for medical use (Humaspect, Table 10.4) is produced by a human lymphoblastoid cell line originally transformed by EBV. 

Adalimumab is a recombinant, fully human antitumor necrosis factor monoclonal antibody approved in the US and Europe for the treatment of adult patients with moderate to severe, active rheumatoid arthritis. It has to be injected subcutaneously. The most common side effects of adalimumab are injection site reactions. Adalimumab increases the risk of rare serious infections. Rare side effects include worsening or initiation of congestive heart failure, a lupus-like syndrome, a promotion of lymphoma, medically significant cytopenias, and worsening or initiation of a multiple sclerosis like neurological disease. 

A major breakthrough in the treatment of lymphoid malignancies was the discovery of monoclonal antibody activity, especially that of rituximab. Rituximab was the first monoclonal antibody approved by the U.S., FDA for the treatment of relapsed follicular lymphoma (1), and it has now been extensively used for the treatment of various lymphoid neoplasm which express CD20 antigen. Its efficacy has been also demonstrated against diffuse large B-cell lymphoma when administered as a combination regimen such as rituximab plus CHOP (R-CHOP) chemotherapy (2). 

Efalizumab is a recombinant humanized anti-CDlla monoclonal antibody approved for the treatment of adult patients with severe... 

Natalizumab (Tysabri), an anti-a4 integrin monoclonal antibody approved for the treatment of multiple sclerosis, was recently withdrawn from the market temporarily due to cases of progressive multifocal leukoencephalopathy, a demyelinating disease of the central nervous system associated with immunosuppression [32], These cases highlight our incomplete understanding of the immune system and the translation of preclinical results to humans. 

Grillo-Lopez AJ, White CA, Varns C, et al. Overview of the clinical development of rituximab first monoclonal antibody approved for treatment of lymphoma. Semin Oncol 1999 26(Suppl 14) 66-73. 

Table 16.1 Therapeutic monoclonal antibodies approved by the US FDA. (Products with an annual turnover of more than US ...

Monoclonal Antibodies Approved for Hematopoietic and Solid Tumors ... 

The rituximab presentation to the Biologies Response Modifiers Advisory Committee (BRMAC) of the FDA took place on July 25, 1997 and the final approval was granted on November 26,1997 (Fig. 4) [55-58]. The EMEA granted approvi to rituximab in Europe in June 1998. Rituximab became the first monoclonal antibody approved for the treatment of cancer and specifically for patients with NHL. 

Table 18.2 summarizes information about the 21 therapeutic monoclonal antibodies approved by the US Food and Drug Administration (FDA) as of 2007. 

TABLE 16.1 Therapeutic Monoclonal Antibodies Approved in the United States [Reichert and Pavolu, 2004]... 

FDA, 2012b. FDA approves raxibacumab to treat inhalational anthrax first monoclonal antibody approved using the Animal Efficacy Rule. Available at [Pg.673]

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