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| |  FDA Panel Recommends Ethyol For Radiation-Induced Xerostomia WEST CONSHOHOCKEN, PA and PALO ALTO, CA -- June 9, 1999 -- The United States Food and Drug Administration’s oncologic drugs advisory committee has recommended the approval of U.S. Bioscience’s and Alza Corp.’s Ethyol(R) (amifostine) for the reduction of moderate-to-severe, post-operative radiation-induced xerostomia (dry mouth) in patients undergoing radiation treatment for head and neck cancer. Generally the FDA follows the recommendation of the ODAC, although it is not required to do so. "To date, there have been almost no alternatives for patients who wished to reduce side effects associated with radiation therapy," explained Walter Curran, Jr., M.D., group chairman of the Radiation Therapy Oncology Group (RTOG), professor and chairman of radiation oncology and clinical director of the Kimmel Cancer Center at Jefferson Medical College, Philadelphia. "Xerostomia, or chronic dry mouth, results from permanent and often irreversible damage to the salivary glands. This can make it difficult for patients to chew, swallow, speak or wear dentures." These events were evaluated in the clinical trials and were considered to support the efficacy of Ethyol. Drug data supporting the safety and efficacy of Ethyol for the reduction of xerostomia, which were submitted by U.S. Bioscience and reviewed by the ODAC, included data from a phase III, open-label, prospective multi-centre randomised trial involving approximately 300 patients with head and neck cancer. At the end of the treatment period 78 percent of patients given radiation alone experienced moderate or severe xerostomia, compared with 51 percent of patients treated with Ethyol prior to radiation. This represented a 35 percent reduction in the incidence of severe xerostomia with the use of Ethyol. Moreover, approximately one year after radiation therapy, 57 percent of the patients in this trial who had been treated with radiation alone were still experiencing severe xerostomia, as compared to 34 percent of the patients in the Ethyol arm. The supplemental New Drug Application (sNDA) for the use of Ethyol to reduce the incidence of severe radiation-induced xerostomia was submitted to the FDA by U.S. Bioscience in December 1998 and was granted priority review status by the FDA. The treatment-related side effects of Ethyol experienced by patients receiving Ethyol plus radiation in the phase III study included in the sNDA were nausea and vomiting, hypotension, fever, allergic-type skin reactions, dizziness/light-headedness, fatigue/lethargy, rigors/chills, sneezing/wheezing, sleepiness/somnolence and flushing. Of the 29 patients who discontinued Ethyol due to side effects (19 percent), all but one continued radiation treatment following discontinuation of Ethyol. Related Links: Ethyol, Alza Corp.
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