FDA PANEL WITHHOLDS RECOMMENDATION TO APPROVE ETHYOL(R)
FDA PANEL WITHHOLDS RECOMMENDATION TO APPROVE ETHYOL(R) WEST CONSHOHOCKEN, Pa., Feb. 3 /PRNewswire/ -- U.S. Bioscience, Inc.
(AMEX: UBS), a pharmaceutical company specializing in the development and commercialization of anticancer compounds, said the Food and Drug Administration's Oncologic Drugs Advisory Committee withheld a recommendation to approve Ethyol(R) (amifostine, WR-2721). Ethyol is a protective agent for use against the serious toxicities associated with chemotherapy and radiation therapy.
While committee members expressed optimism about the possible future medical benefit of Ethyol, they indicated additional data would be required to support the indications requested. Certain aspects of the clinical data were generally regarded as strong, including reduction of hematologic toxicity associated with cyclophosphamide, particularly hospitalization from neutropenic fever which can be life-threatening. However, other data supporting the diminution of toxicities related to cisplatin, including neurological and otological toxicities, will require additional study. The committee also said that, while there is no reason to expect a tumor to be protected by Ethyol, the data needs to mature. During the latter part of 1991, with the concurrence of the FDA, the company had suspended the accrual of patients to its pivotal trial of Ethyol in ovarian cancer. "This study will be reopened and the accrual of patients will be completed as rapidly as possible," said Phillip S. Schein, M.D., president and chief executive officer. "To date, 146 patients have been enrolled in this study, with additional patients being accrued in Europe following the suspension of the U.S. trial. The protocol indicated 200 patients should be enrolled. The company will make every effort to promptly complete the patient accrual on this study and submit this information to the FDA." Based in West Conshohocken, Pa., U.S. Bioscience is a pharmaceutical company specializing in the development and commercialization of products to increase the survival and quality of life for patients with cancer and allied diseases. The company's portfolio includes a broad spectrum of cancer treatments, including four products in the final stages of development. One product, Hexalen(R), is approved in the United States for the treatment of ovarian cancer. -0- 2/3/92 /CONTACT: Robert I. Kriebel of U.S. Bioscience, Inc., 215-832-4503; or Charles Versaggi of Versaggi & Associates, 408-358-4162 or 408-395-1877, for U.S. Bioscience, Inc./ (UBS) CO: U.S. Bioscience, Inc. ST: Pennsylvania IN: MTC SU:
ML -- NYON1 -- 5976 02/03/92 08:04 EST
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|Date:||Feb 3, 1992|
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