SNMMI Applauds FDA Approval of Tc 99m Tilmanocept (Lymphoseek)

March 14, 2013

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) commends the US Food and Drug Administration (FDA) for its approval of Tc 99m tilmanocept (Lymphoseek) injection. The radioactive diagnostic imaging agent is designed for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. By quickly and accurately identifying lymph node involvement, Tc 99m tilmanocept will help physicians in staging and management of disease. Accurate staging of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence.

Tc 99m tilmanocept is the first new drug used for lymph node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph node mapping include sulfur colloid (1974) and isosulfan blue (1981).

SNMMI encourages the FDA to continue reviewing and, when appropriate, approving other nuclear medicine and molecular imaging radiopharmaceuticals that can play a role in improving patient care.