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ALDESLEUKIN APPROVED FOR TREATMENT OF KIDNEY CANCER

 ALDESLEUKIN APPROVED FOR TREATMENT OF KIDNEY CANCER
 WASHINGTON, May 5 /PRNewswire/ -- The Food and Drug


Administration today announced the licensing of a genetically engineered product, aldesleukin, for the treatment of metastatic renal cell carcinoma (kidney cancer) in adults.
 Aldesleukin is the first FDA-approved drug treatment specifically for kidney cancer, a disease which accounts for about 10,000 deaths each year. Derived from genetically engineered bacteria that contain an analog of the human interleukin-2, aldesleukin is a lymphokine involved in regulating immune response.
 While aldesleukin is not a cure and most patients in clinical trials experienced serious side effects, the drug will provide some patients a treatment alternative.
 "This treatment represents one of the first successful attempts to fight cancer by augmenting the function of the body's immune system," said FDA Commissioner David A. Kessler, M.D. "Immunotherapy using aldesleukin is an example of the potential for modern biotechnology to improve health care."
 In seven clinical trials involving 21 institutions, 255 patients with metastatic renal cell cancer were treated with aldesleukin. The drug reduced the size of tumors in 15 percent of the patients; 4 percent of the patients had all evidence of their tumors disappear for about 23 months, and 11 percent reported a substantial reduction in the size of the tumor for nearly 19 months.
 However, most of the patients in the clinical trials experienced severe side effects, and many experienced life-threatening side effects. Patients usually recovered from side effects after therapy, but in 11 of the 255 patients (4 percent), drug-related side effects resulted in death.
 The toxicities included capillary leak syndrome -- the passing of plasma proteins and fluid outside the blood vessels. Capillary leak syndrome can result in hypotension and reduced circulation of blood in the organs, which may be severe and can result in death.
 Other serious adverse reactions included cardiac arrhythmias, angina, myocardial infarction, respiratory failure, gastrointestinal bleeding, kidney failure (requiring dialysis), neurologic problems and infections. Most of the adverse reactions were usually reversible within two or three days after discontinuing treatment.
 Because of these severe adverse reactions, the agency has labeled aldesleukin to be administered intravenously only in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer drugs. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available. The labeling requirements of this drug also should restrict the treatment to patients with normal cardiac and pulmonary functions.
 In 1988, aldesleukin was designated an orphan drug -- a designation which provides incentives for manufacturers to develop and produce medical products to treat rare diseases and conditions. On Jan. 17, 1992, the Biologic Response Modifiers Advisory Committee recommended that the drug be approved for metastatic renal cell carcinoma with labeling that alerts physicians to the toxic effects associated with its administration.
 Aldesleukin is manufactured by Chiron Corporation of Emeryville, Calif., and will be distributed by Cetus Oncology Corporation under the trade name Proleukin. The product will be commercially available in mid-May.
 -0- 5/5/92
 /NOTE: TV Broadcasters please use open caption for the hearing impaired./
 /CONTACT: Monica Revelle of the Food and Drug Administration, 301-443-4177 or, after hours, 410-290-6575/ CO: U.S. Department of Health and Human Services ST: Maryland IN: MTC SU:


TW -- DC023 -- 6773 05/05/92 17:00 EDT
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Date:May 5, 1992
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