Immunomedics regulatory update

The FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) will review IMMU’s CEA-Scan colorectal cancer imaging agent on Feb. 16. CEA-Scan consists of a fragment of a mouse monoclonal antibody against carcinoembryonic antigen (CEA), a tumor marker.

In October, the Oncologic Drugs Advisory Committee deferred a decision on the approvability of CEA-Scan and recommended that the product be reviewed by MIDAC and oncology consultants. ODAC further recommended that the company and the FDA resolve differences in data and imaging interpretation. ...