Lymphoseek

Generic Name: technetium Tc 99m tilmanocept
Date of Approval: March 13, 2013
Company: Navidea Biopharmaceuticals, Inc.

Treatment for: Use in Lymphatic Mapping

FDA Approves Lymphoseek

The U.S. Food and Drug Administration (FDA) has approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a novel product indicated 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. Lymphoseek is a receptor targeted radiopharmaceutical designed to identify these lymph nodes which have the highest probability of harboring cancer and thereby assist physicians in the staging of such patients.

What is Lymphoseek?

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer, in patients with breast cancer or melanoma.

Slideshow: Flashback: FDA Drug Approvals 2013

What is Lymphoseek Used For?

Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Lymphoseek side effects

The most common adverse reactions are injection site irritation and/or pain (<1%).

Hide
(web5)