BETHESDA, Md. -- An advisory committee recommended on Fridaythat the Food and Drug Administration approve Chiron Corp.'sProleukin interleukin-2 for metastatic renal carcinoma patientswho are asymptomatic or are symptomatic but ambulatory.
The drug would be the first approved treatment for kidneycancer, which kills about 10,000 patients in the United Stateseach year.
Chiron stock (NASDAQ:CHIR) closed at $69, up 25 cents.
The Biological Response Modifiers Advisory Committee in July1990 had rejected the same application when it was made byCetus Corp., now part of Chiron. In its refusal, the committeesaid Proleukin was an "unfinished product." The FDA criticizedCetus for insufficiently analyzing data and failing to follow uppatients adequately.
On Friday, several panelists cited a doubling in the patient trialdata base and careful studies conducted under the auspices ofthe FDA in their decision to recommend approval.
Panel members said the expanded tests demonstrated clearbenefits for some metastatic renal cancer patients undergoingProleukin therapy. The company presented data indicating that3.5 percent of patients in trials achieved a complete response -- meaning elimination of all tumors and symptoms -- and 11.5percent achieved a partial response.
The committee recommended the drug be approved formetastatic renal carcinoma patients with a performance statusof zero, indicating that there are no symptoms. It alsorecommended that the drug be approved for patients with aperformance status of one -- those who have symptoms but areambulatory -- provided that the labeling warns that risks fromtoxicity pose a serious threat to status one patients.
Chiron's data indicated that 4 percent of the patients in itstrials died as a result of the product's toxicity. A largepercentage of the patients had to be treated in intensive careunits to manage toxic side effects.
The committee recommended a specific dosage and diluent forProleukin and said the company should perform further animaland clinical studies.
Proleukin was approved for metastatic renal carcinoma inEurope in 1989. Hollings Renton, Chiron president and chiefoperating officer, told BioWorld that annual European sales areabout $15 million. He said the patient populations in Europeand the United States are of similar size, and the U.S. cost islikely to approximate the European price of $7,000 per courseof therapy.
Renton said that Chiron is working on other Proleukinapplications, including combined Proleukin and alpha-interferon for renal carcinoma and Proleukin combined withchemotherapies for melanoma.
-- Steve Usdin BioWorld Washington Bureau
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