Reuters Health Information (2009-10-01): "Substantial" toxicity with peginterferon use: FDA staff
"Substantial" toxicity with peginterferon use: FDA staff
Last Updated: 2009-10-01 19:30:14 -0400 (Reuters Health)
WASHINGTON (Reuters) - Schering-Plough Corp's injectable drug PegIntron (peginterferon) carries "substantial toxicity" and had no effect on overall survival in melanoma skin cancer patients undergoing surgery, U.S. Food and Drug Administration staff reviewers said in documents released on Thursday.
Schering is seeking FDA approval to sell PegIntron for use with surgery in cases where the melanoma has spread to the lymph nodes.
PegIntron is already approved for liver disease in conjunction with the company's Rebetol (ribavirin) for chronic hepatitis C.
The FDA released the documents ahead of an advisory committee meeting on Monday to discuss whether to approve the drug. The agency usually takes the advice of its outside experts.