FDA approves lymph node mapping agent
The US FDA has approved Ohio biopharma Navidea’s Lymphoseek, which is a radioactive diagnostic imaging agent that can help doctors locate lymph nodes in patients with breast cancer or melanoma who are und
ergoing surgery to remove tumour-draining lymph nodes.
Lymphoseek (technetium Tc 99m tilmanocept) Injection is the first new imaging drug to be approved in over 30 years that helps locate lymph nodes, but it is not a cancer imaging drug.
“Removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation for some patients with breast cancer or melanoma. 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.”
Shaw Chen, M.D., deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research.
Two clinical trials evaluated Lymphoseek’s safety and effectiveness – 332 patients with melanoma or breast cancer were involved. All patients were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes. Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and / or Lymphoseek. Results showed Lymphoseek and blue dye had localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek.
FDA approves imaging drug for cancer lymph nodes (USA Today)
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