FDA approves Lymphoseek for lymph node mapping

The Food and Drug Administration has approved Lymphoseek, a radioactive diagnostic imaging agent to locate lymph nodes in patients with certain cancers, including melanoma.

The approval of Lymphoseek (technetium Tc 99m tilmanocept, Navidea Biopharmaceuticals) injection marks the first new drug for lymph node mapping in more than 30 years, according to a news release. The imaging drug allows physicians treating patients with melanoma or breast cancer to locate tumor-draining lymph nodes.

Lymphoseek’s effectiveness was established in two clinical trials of 332 patients with melanoma or breast cancer. Clinicians injected the patients’ tumors with Lymphoseek and blue dye, which is also used to locate lymph nodes. Clinicians then used a handheld radiation detector to locate lymph nodes that took up the drug’s radioactivity.

After surgeons removed suspected lymph nodes for pathological examination, they examined confirmed lymph nodes for the presence 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,” the FDA stated.

Common side effects from Lymphoseek included pain or irritation at the injection site.