FDA approves CEA-Scan
This article was originally published in Clinica
Executive Summary
The US FDA has approved Immunomedics' colorectal cancer imaging agent, CEA-Scan. The FDA has licensed the technetium-labelled antibody fragment for use in conjunction with standard diagnostic procedures - particularly CT - for detection and localisation of recurrent or metastatic disease in the abdomino-pelvic region. It will be distributed by Mallinckrodt in the US and Europe, where it was recommended for approval in May (see Clinica No 707, p 16). It will be launched in the US this autumn.