Immunodiagnostic Label Expansion

What We Are Working On

Navidea’s efforts to exploit the involvement of macrophages in the natural history of many diseases, has led us to our strategy of expanding the Lymphoseek® (technetium Tc 99m tilmanocept) injection label and opening new opportunities that have addressable markets which are substantially larger than the current Lymphoseek indications in Oncology.  Lymphoseek’s active ingredient, tilmanocept, is highly specific and selective for a receptor found on the surface of macrophages.  This targeted mechanism of action has opened the potential for Lymphoseek (tilmanocept) as an immunodiagnostic in inflammatory and other disease areas such as rheumatoid arthritis (RA), Kaposi’s sarcoma, and cardiovascular disease, among others. The current status of our pipeline development efforts are shown here.

 Label Expansion

Lymphoseek Indication and Important Safety Information

 

Indication

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

  • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
  • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, 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.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

Please see full Prescribing Information.

To report suspected adverse reactions, contact Navidea Biopharmaceuticals, Inc. at 1-800-476-5270 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.