IMMUNOMEDICS CEA-SCAN COLORECTAL CANCER IMAGING AGENT REVIEW DEFERRED BY FDA CMTE.; CLINICAL UTILITY MAY BE TOO DIFFICULT TO ASSESS FOR DIAGNOSTICS
This article was originally published in The Gray Sheet
Executive Summary
The review of Immunomedics' monoclonal antibody-based CEA-Scan product license application for imaging in colorectal cancers was postponed by FDA's Oncologic Drugs Advisory Committee on Oct. 17 until FDA and the sponsor resolve issues concerning analyses and data to be presented to the committee.