BioCentury
ARTICLE | Regulation

This time it's unanimous

February 20, 1996 8:00 AM UTC

SILVER SPRING, Md - The second time was lucky for Immunomedics Inc., which on Friday received the endorsement of an FDA advisory committee for its CEA-Scan colorectal imaging agent.

The Medical Imaging Drugs Advisory Committee unanimously voted to recommend approval of CEA-Scan as an imaging agent for recurring colorectal cancer. MIDAC members specified that the product, a monoclonal antibody fab' fragment labeled with technetium-99m, only should be used in conjunction with CT scans or other diagnostic procedures that may be developed in the future. Its primary utility is in staging colorectal cancer patients to determine whether they can be treated surgically...