ROCKVILLE, Md--The FDA's Oncologic Drugs Advisory Committee has declined to recommend Ethyol (amifostine injection, U.S. Bioscience, Inc.) for approval at this time. The drug is being considered as a cytoprotective agent against both the acute and cumulative hematologic and renal toxicities associated with alkylating agents such as cyclophosphamide(Drug information on cyclophosphamide) (Cytoxan, Neo-sar) and platinum agents such as cisplatin(Drug information on cisplatin) (Platinol) in patients with ovarian cancer.
Although there was general agreement among the committee members that amifostine(Drug information on amifostine) does indeed have a biologic effect, they found that the data submitted did not make clear whether that effect is sufficient for approval.
Robert L. Capizzi, MD, U.S. Bioscience executive president, said that the company has since had a constructive meeting with the FDA, resulting in an FDA proposal that the company submit an amendment to its NDA for Ethyol based on analyses of the existing clinical data. The company intends to submit this amendment and anticipates returning to the committee by mid-year 1995.
He added that the recent recommendation for approval of the drug in Europe and the anticipated commercial sale in the United Kingdom should provide opportunities to demonstrate Ethyol's clinical benefit for cancer patients.
A U.S. Bioscience representative said that the treatment for ovarian cancer patients has improved somewhat over the past several years but at a great cost in toxicity.
In its presentation of Ethyol trials in patients with advanced ovarian cancer and melanoma being treated with alkylating and platinum agents, the company claimed that pretreatment with Ethyol led to a significant decrease in hematologic, renal, neurologic, and otologic drug toxicity, without reducing the antitumor effects of chemotherapy.
U.S. Bioscience representatives also said that use of Ethyol decreased the incidence of infections associated with neutropenic fevers, resulting in fewer days of hospitalization and fewer days on antibiotics in the ovarian cancer trials.