Monday, June 12, 1995
Ethyol finally passes muster
By Steve Usdin
WASHINGTON - U.S. Bioscience got it right the third time, receiving a positive recommendation on Friday from the FDA's Oncologic Drugs Advisory Committee for Ethyol six months after ODAC recommended against approval. The FDA also rejected the drug in 1992.
The panel strongly endorsed the use of Ethyol (amifostine) as a chemoprotective agent for use with cisplatin in the treatment of ovarian cancer. It was divided, however, on whether the drug should receive an unconditional approval or if an accelerated approval was more appropriate.
Accelerated approvals require that the sponsor perform specific actions, such as additional clinical trials, and provide positive results in order for the drug to stay on the market.
Four ODAC members voted in favor and four voted against recommending unconditional approval of Ethyol as a chemoprotective to be used in ovarian cancer therapy in conjunction with six courses of cisplatin delivered at a dose of 100 mg/m