The US Food and Drug Administration has announced the approval of Lymphoseek (technetium Tc 99m tilmanocept) Injection, 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.
Lymphoseek is an imaging drug. It helps locate lymph nodes; it is not a cancer imaging drug.
The body's lymph nodes filter lymphatic fluid from tissues which may contain cancer cells if the patient has cancer and especially if the fluid is draining a part of the body where a tumor resides. Doctors can sometimes determine whether a cancer has begun to metastasize by excising the lymph nodes that drain near a tumor.
Lymphoseek is the first new drug used for lymph node mapping to be approved by the FDA in more than three decades. Other, previously approved drugs for this indication include sulfur colloid (1974) and isosulfan blue (1981).
Said Shaw Chen, M.D., deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research:
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.
Lymphoseek’s safety and effectiveness were established in two clinical trials of 332 patients with either melanoma or breast cancer.
Source: FDA
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