FDA Approves Chiron's Proleukin

Treating skin cancer and kidney cancer that has spread to other parts of the body. Proleukin is an antineoplastic. It works by helping enhance many aspects of the immune system, which helps to decrease growth of the cancer cells.

PROLEUKIN (aldesleukin) for injection is a recombinant human interleukin-2 (rhIL-2) for treatment in adults with metastatic melanoma and metastatic kidney cancer. PROLEUKIN therapy is a form of immunotherapy that uses the body's natural immune system to fight cancer.

PROLEUKIN has been used for over 10 years in the treatment of metastatic melanoma and over 15 years in the treatment of metastatic kidney cancer (renal cell carcinoma). Studies have demonstrated that PROLEUKIN therapy offers the possibility of a complete and long-lasting response in these diseases.

Aldesleukin is used to treat advanced forms of kidney or skin cancer (cancer that has spread to other parts of the body). This medication is the same as a substance that your body normally makes (interleukin-2). In the body, this drug is thought to work by affecting the body's natural defenses (immune system). This effect slows or stops cancer cell growth.

Proleukin, a lymphokine, is produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human interleukin-2 gene. Genetic engineering techniques were used to modify the human IL-2 gene, and the resulting expression clone encodes a modified human interleukin-2. This recombinant form differs from native interleukin-2 in the following ways: a) proleukin is not glycosylated because it is derived from E. coli ; b) the molecule has no N-terminal alanine; the codon for this amino acid was deleted during the genetic engineering procedure; c) the molecule has serine substituted for cysteine at amino acid position 125.