Lymphoseek Approved; Maps Cancerous Lymph Nodes

The FDA announced the approval of Lymphoseek (technetium Tc 99m tilmanocept; Navidea) Injection, a radioactive diagnostic imaging agent to locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Doctors inject the drug into the tumor area and can use a handheld radiation detector to find the lymph nodes that have taken up Lymphoseek's radioactivity.

The safety and effectiveness of Lymphoseek were established in two clinical trials (n=332) with melanoma or breast cancer. All patients were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes. Surgeons removed suspected lymph nodes for pathologic examination, and 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.

Lymphoseek will be sold and distributed in the U.S. on an exclusive basis by Cardinal Health, Inc.

For more information call (800) 793-0079 or visit www.navidea.com.