WASHINGTON _ An FDA advisory committee voted unanimouslytoday not to recommend agency approval of U.S. Bioscience'sEthyol for protection against certain toxicities of chemotherapy inovarian cancer patients. The panel concluded that while the clinicaldata showed "suggestive evidence" of Ethyol's ability to decreasechemotherapy-related adverse events, it did not provide conclusiveproof of efficacy.
Monday's recommendation marks the second time that Ethyol hasbeen rejected by the FDA's Oncologic Drugs Advisory Committee_ more than two years ago, on Jan. 31, 1992, the committeerecommended against agency approval of Ethyol and called for moreclinical data. On that date, the company's stock plunged $13.75 pershare (44 percent) _ to close at $17.75 _ on the news.
Trading in U.S. Bioscience stock (AMEX:UBS) was halted by theAmerican Stock Exchange all day on Monday due to "newspending." The stock thus closed unchanged at $6.38 per share.According to U.S. Bioscience spokeswoman Ellen Evans, thedecision to halt trading was made by the exchange, not the company.AMEX could not be reached for comment at press time.
An amended new drug application (NDA) submitted last July byWest Conshohocken, Pa.-based U.S. Bioscience included data on242 patients, exactly double the number of patients included in theoriginal Ethyol NDA. (See BioWorld Today, July 14, 1994, p. 1.)Technically, the indication sought for Ethyol on Monday was "as acytoprotective agent against both the acute and cumulativehematologic and renal toxicities associated with alkylating agentssuch as cyclophosphamide and platinum agents such as cisplatin inpatients with ovarian cancer."
The pivotal Phase III trial of Ethyol that formed the basis of the mostrecent NDA filing was reported last May at the annual meeting of theAmerican Society of Clinical Oncology (ASCO). While only 9percent of Ethyol-treated patients in the study dropped out of acombination chemotherapy regimen due to toxicities, 39 percent ofpatients in the control group (chemotherapy drugs only) dropped out.The results were considered promising by some analysts, includingthose at Vector Securities International and Hambrecht & Quist Inc.,who recommended that their clients accumulate U.S. Biosciencestock in anticipation of FDA approval.
On Sept. 13, the European Union's (EU) Committee for ProprietaryMedicinal Products recommended approval of Ethyol to reduce theneutropenia-related risk of infection associated with the combinationchemotherapy regimen of cyclophosphamide and cisplatin in patientswith advanced ovarian cancer. (See BioWorld Today, Sept. 21, 1994,p. 2.) Nine of the 12 EU countries recommended approval of thedrug _ Belgium, France, Germany, Greece, Italy, Luxemburg,Portugal, Spain and the U.K. The company must now seek approvalsfrom individual EU member countries. On Nov. 30, the U.K.'sMedicines Control Agency granted a product license for themarketing of Ethyol.
Late Monday, U.S. Bioscience spokeswoman Ellen Evans said thatthe company was preparing a statement for release before the stockmarket opens on Tuesday. That statement was still unavailable atpress time. With approximately $30 million in cash and cashequivalents and a burn rate of $25 million, U.S. Bioscience has lessthan a year's worth of financing left. n
-- Lisa Piercey Washington Editor
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