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In Brief: Immunomedics CEA-Scan

Executive Summary

Immunomedics CEA-Scan: Diagnostic imaging agent demonstrates 60% accuracy in predicting tumor resectability in patients with known or suspected recurrent colorectal cancer compared to 47% for diagnosis via computed tomography, Immunomedics announces. In a 208-patient Phase III study, radioimmunodetection using the Tc-labeled Fab' fragment of the murine anti-CEA IMMU-4 monoclonal antibody was correct more often (69%) than CT (31%) when there were differing assessments of resectability, Immunomedics says. A PLA filing for CEA-Scan in 1991 resulted in a May 1994 "not approvable" letter from FDA. Immunomedics submitted the additional data in March in response to FDA's request to demonstrate the agent's clinical utility...
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PS026275

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