First Approval For Ethyol, But FDA Panel Says No

US Biosciences' chemoprotectant agent Ethyol (amifostine) has been approved for marketing in its first market, the UK. The drug was recently recommended for approval by the European Union's Committee on Proprietary Medicinal Products (Marketletter October 3), with nine of the 12 EU countries returning a positive position on the drug. USB's Neutrexin (trimetrexate glucuronate) was also recommended at that time for Pneumocystis carinii pneumonia in AIDS patients.

Ethyol is indicated for the reduction of neutropenia-related infection resulting from use of a combination of cyclophosphamide and cisplatin in patients with advanced ovarian cancer. It will be launched by licensee Schering-Plough in the first quarter of 1995, according to managing director of S-P's UK arm, Peter Martin. Schering-Plough has rights to the agent in Europe, including the European Union and European Free Trade Area countries, as well as markets in eastern Europe, Latin America and the Far East. USB retains rights for the drug in North America.

Meantime, the US Food and Drug Administration's Oncologic Drugs Advisory Committee has rejected USB's application for approval of amifostine for the second time. Nearly three years ago (January 31, 1992), the panel called for more clinical data on the safety of the product, particularly with regard to its potential of shielding the tumor from the chemotherapy used to treat it, before it would give its backing.