FDA delays action on Immunomedics agent
Monoclonal antibody developer Immunomedics suffered a blow fromthe Food and Drug Administration last week. The agency's oncologicdrugs advisory committee deferred a decision on the company'sCEA-Scan colorectal cancer imaging agent and recommended thatit
Monoclonal antibody developer Immunomedics suffered a blow fromthe Food and Drug Administration last week. The agency's oncologicdrugs advisory committee deferred a decision on the company'sCEA-Scan colorectal cancer imaging agent and recommended thatit be reviewed by another FDA committee. News of the committee'sdecision caused the Morris Plains, NJ, company's stock to drop26% to $5.75 a share on Oct. 18.
The FDA last year issued Immunomedics a non-approvable letterfor CEA-Scan (SCAN 9/27/95). Immunomedics said it will continueto work with the FDA to receive approval for the agent.