Regulatory Focus™ > News Articles > US Regulators Approve Lymph Node Mapping Diagnostic Imaging Agent

US Regulators Approve Lymph Node Mapping Diagnostic Imaging Agent

Posted 13 March 2013 | By Alexander Gaffney, RAC

US regulators have approved a new radioactive diagnostic imaging agent manufactured by Navidea Biopharmaceuticals that is intended to assist in the location of lymph nodes in patients with breast cancer or melanoma.

The approval, FDA's sixth of the 2013 calendar year, is the first new drug used for lymph node mapping to be approved in more than 30 years, FDA explained. At least two other products are approved for the condition, including sulfur colloid and isosulfan blue, but none have been approved since 1981.

"Removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation for some patients with breast cancer or melanoma," said Shaw Chen, deputy director of the Office of Drug Evaluation IV in the FDA's Center for Drug Evaluation and Research.

The point of the drug, Navidea explains on its website, is to avoid having to remove non-cancerous lymph nodes which otherwise cause significant pain, potential adverse side effects and little benefit to patients.

"To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek's radioactivity," FDA explained. Findings from the initial lymph node-the sentinel node-are effective in determining with 95% certainty whether the remaining lymph nodes on their respective continuums are cancerous, the company added.

FDA noted that the imaging agent was tested in two clinical trials of 332 patients with either melanoma or breast cancer. "A notable number of nodes were localized only by Lymphoseek" and not isosulfan blue dye, regulators added. Side effects were seen as being minor, with the most common being pain or irritation at the site of injection.

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