OCTREOSCAN APPROVED IN USA

Mallinckrodt has received approval for its scintigraphic imaging agent OctreoScan (indium-111 pentreotide) from the US Food and Drug Administration. The product will be launched this month. The price of the agent was not disclosed.

The agent is indicated "for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors," primarily stomach, lung and thyroid tumors. The approved labelling notes that the agent localized previously-unidentified tumors in 57 of 204 patients, and in 55 of 195 patients uptake of the agent occurred in lesions not thought to have somatostatin receptors.

The agency said that the company needed to conduct testing in larger trials to prove that the product outperforms computerized tomography or magnetic resonance imaging scans in the detection of neuroendocrine tumors. "There is inadequate evidence that the product, as a diagnostic agent, is more sensitive or more specific than CT or MRI," noted the agency. According to the company, in a trial of 39 patients the sensitivity of OctreoScan was 86% compared to 68% for CT and MRI, and the specificity was 50% compared to 12% for CT and MRI.