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| |  Ethyol Receives Additional Indication for Non-Small Cell Lung Cancer WEST CONSHOHOCKEN, Pa., March 18, 1996 -- U.S. Bioscience, Inc. (AMEX: UBS) and ALZA Corporation (NYSE: AZA) today announced that the Food and Drug Administration (FDA) granted marketing clearance for expanded labeling for the new agent Ethyol(R) (amifostine) to include use in patients with non-small cell lung cancer for the reduction of cumulative renal (kidney) damage associated with repeated administration of cisplatin-based chemotherapy. U.S. Bioscience received initial clearance to market Ethyol(R) to reduce the cumulative kidney toxicity associated with the administration of cisplatin in patients with advanced ovarian cancer in December 1995. The expanded labeling for non- small cell lung cancer was granted under the Accelerated Approval Regulations which require the company to conduct a post marketing controlled clinical trial in patients with non-small cell lung cancer to verify and describe clinical benefit in this patient population. The required study is now in progress. According to the American Cancer Society, it is estimated that there will be 177,000 new cases of lung cancer in the United States this year, and it is the leading cause of cancer death in adults. Non-small cell lung cancer accounts for approximately 75 percent of all lung cancers. Cisplatin is among the most frequently prescribed chemotherapeutic agents for this disease. Ethyol is given at the initiation of cisplatin- based therapy to reduce the cumulative kidney damage that can result from repeated administration of cisplatin. Ethyol will be marketed by ALZA Corporation for an initial period of five years during which time the U.S. Bioscience sales force will co-promote the product. After the initial period, marketing rights to Ethyol will revert to U.S. Bioscience. Ethyol will be commercially available in early 1996. "We're delighted with the FDA's prompt decision to expand the indication to include use in patients with non-small cell lung cancer," said Philip S. Schein, M.D., Chairman and CEO of U.S. Bioscience, Inc. "This expanded label represents an important step in establishing Ethyol as a critical component of cisplatin-based therapy." Consistent with the results from the randomized trial of Ethyol in ovarian cancer, a Phase II trial of Ethyol plus high dose cisplatin in combination with vinblastine in patients with advanced non-small cell lung cancer conducted at the University of Wisconsin demonstrated that despite administration of repeated cycles of high dose cisplatin, the regimen was generally well tolerated in respect to preservation of renal function. "We were impressed by the response rates and survivals observed with this Ethyol and cisplatin-based regimen which compares favorably to other chemotherapy regimens commonly employed for non-small cell lung cancer," commented Joan Schiller, M.D., Associate Professor Department of Medicine, University of Wisconsin. The results of Dr. Schiller's study formed the basis for the ongoing randomized Phase III trial of cisplatin-based therapy, with and without Ethyol in patients with non-small cell lung cancer. This trial may fulfill the company's requirements under the Accelerated Approval Regulations. "This expanded indication is an important development for cancer patients," said Samuel R. Saks, M.D., ALZA's Senior Vice President of Medical Affairs. "Ethyol will be a significant adjunct to cisplatin-based chemotherapy for patients with ovarian or non-small cell lung cancer because of its ability to protect healthy cells without appearing to alter anti-tumor activity," continued Dr. Saks. "By reducing kidney toxicity, Ethyol reduces the likelihood of delays or discontinuation in a cancer patient's treatment regimen," he added. Chemotherapy agents generally are not selective in their effects and can damage or destroy healthy tissue because of their inability to discriminate between cancer and normal cells. Ethyol has demonstrated the ability to protect the kidney and the clinical data do not suggest any interference with the cytotoxic activity of cisplatin-based chemotherapy in both ovarian and non-small cell lung cancer. Ethyol is being further investigated in other tumor types utilizing different chemotherapeutic combinations, as well as in radiation therapy. U.S. Bioscience, Inc., based in West Conshohocken, Pennsylvania, is a pharmaceutical company specializing in the development and commercialization of products for patients with cancer and AIDS. Ethyol represents the company's third product achieving FDA clearance for marketing. ALZA Corporation, headquartered in Palo Alto, California, is a leader in the development and commercialization of innovative pharmaceutical products using advanced drug delivery technologies to add medical and economic value to drug therapies.
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