Compound Name:AldesleukinMolecular Target:IL-2RMolecular Structure:Modified recombinant human IL-2Licensed Indication:Metastatic renal cell carcinoma, metastatic melanomaManufacturer and/or Distributor:Prometheus LaboratoriesInitial FDA Approval:1992Summary:

Aldesleukin is a modified recombinant interleukin-2 (IL-2) that is produced in E. coli. Although the in vitro biological activities of aldesleukin, such as enhancement of lymphocyte mitogenesis, induction of cytotoxic activity of lymphocytes, natural killer cells, and lymphokine-activated killer cells, have been found to be equivalent to those of native, physiologic IL-2, it differs chemically in two amino acids and it is not glycosylated. In vivo it causes immune activation characterized by marked lymphocytosis, eosinophilia, thrombocytopenia, and the upregulation of cytokines including IL-1, TNF, and g-interferon.


Aldesleukin was approved in 1993 for treatment of metastatic renal cell carcinoma and in 1998 for the metastatic melanoma. In both diseases, a small number of patients (~15%) showed partial or complete responses. The mechanism of its in vivo anti-tumor effect is not understood.
Aldesleukin has been investigated in several other diseases including acute myelogenous leukemia, non-Hodgkin’s lymphoma, HIV infection and Kaposi’s sarcoma.


Aldesleukin administration is often accompanied by severe adverse reactions involving the cardiac, pulmonary, GI and nervous systems, as well as capillary leak syndrome, exacerbations of autoimmune diseases, disseminated infections, and delayed reactions to contrast media. It has Pregnancy Category C.


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