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Lymphoseek Approved by FDA

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First new lymph node mapping drug to be approved in over 30 years

Lymphoseek (technetium Tc 99m tilmanocept) Injection was recently approved by the FDA for use in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. It is not a cancer imaging drug, but the radioactive diagnostic imaging agent assists in locating the lymph nodes.

According to 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.”

Two clinical trials of 332 patients with melanoma or breast cancer determined the safety and effectiveness of Lymphoseek. Study results showed Lymphoseek and isosulfan blue dye (another drug used to help locate lymph nodes) had localized most lymph nodes. However, a notable number of lymph nodes were found only by Lymphoseek.

Pain or irritation at the injection site was the most common side effects noted during clinical trials.

Source: FDA.