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MALLINCKRODT OCTREOSCAN SUPERIORITY TO CT OR MRI

This article was originally published in The Gray Sheet

Executive Summary

MALLINCKRODT OCTREOSCAN SUPERIORITY TO CT OR MRI in detecting neuroendocrine tumors will need to be established in larger trials than have been performed, FDA said in its approval letter for the indium-111 pentreotide imaging agent. "There is inadequate evidence that this product, as a diagnostic agent, is more sensitive or more specific" than computerized tomography or magnetic resonance imaging, the agency maintained. FDA, however, gave OctreoScan a "1P" rating which designates a new molecular entity receiving a priority review, presumably for its superiority to existing therapies.
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