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Lymphoseek approved to locate lymph nodes in breast cancer, melanoma
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The FDA today approved technetium Tc 99m tilmanocept to help in the location of lymph nodes in patients with breast cancer or melanoma.
Technetium Tc 99m tilmanocept (Lymphoseek Injection, Navidea Biopharmaceuticals) is a radioactive diagnostic imaging agent.
The approval is for patients undergoing tumor-draining lymph node removal surgery.
“Removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation for some patients with breast cancer or melanoma,” Shaw Chen, MD, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research, said in apress release. “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.”
The FDA based its approval in part on two clinical trials that evaluated the agent’s safety and efficacy in 332 patients. The findings indicated that a notable proportion of nodes were localized by Lymphoseek.
The adverse event profile showed pain or irritation at the injection site.
The last such imaging agents approved by the FDA were sulfur colloid, approved in 1974, and isosulfan blue, approved in 1981.
Perspective
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Adam M. Brufsky, MD, PhD, FACP
In an era where sentinel lymph node biopsy has become the standard of care in the staging of breast cancer, we are always looking for better and more accurate methods to detect sentinel nodes. The FDA approval of technetium Tc 99m tilmanocept represents recognition of the utility of this agent in the detection of sentinel lymph nodes. Many surgeons use Tc 99m for lymph node detection, and many do not, opting instead for dye detection only. It will be interesting to see how many surgeons return to Tc 99m in their practice, and how many surgeons extend the use of Tc 99m in their practice, now that this agent has formal FDA approval.
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