CEA-Scan gets approvable letter from FDA

It's been a long road back for monoclonal antibody developer Immunomedicsand its CEA-Scan imaging agent, but the end is finally in sight.The Morris Plains, NJ, company reported this month that the Foodand Drug Administration has issued an approvable letter for theagent.

CEA-Scan's path through the FDA's regulatory maze was entangledin 1994 when the agency issued a non-approvable letter for thecolorectal cancer imaging agent. Immunomedics worked with theagency to bring CEA-Scan's product license application (PLA) intoa form that FDA reviewers could accept, and an FDA panel recommendedapproval of the product in February (SCAN 2/28/96).

Final marketing approval for CEA-Scan is now subject mainlyto product labeling, Immunomedics said. Immunomedics has assignedU.S. marketing rights for the agent to Mallinckrodt Medical (SCAN4/10/96).