First Lymph Node Mapping Drug Approved in More than 30 Years

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DUBLIN, OH – The U.S. Food and Drug Administration recently approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, the first new drug used for lymph node mapping to be approved in more than 30 years.

Lymphoseek is a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. The agency emphasized that Lymphoseek is an imaging drug that helps locate lymph nodes, not a cancer imaging drug.

Other FDA-approved drugs used for lymph node mapping include sulfur colloid (1974) and isosulfan blue (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, MD, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research. “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.”

Lymphoseek is marketed by Navidea Biopharmaceuticals, Inc. based in Dublin, OH.

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