FDA approve Lymphoseek to evaluate head and neck cancer

The US Food and Drug Administration have given the OK for doctors to use Lymphoseek - a radioactive diagnostic imaging agent - to evaluate the spread of squamous cell carcinoma in the body's head and neck region.
Lymphoseek (technetium 99m tilmanocept) Injection was approved by the Food and Drug Administration (FDA) in 2013 to help doctors identify lymph nodes closest to primary tumors in patients with breast cancer and melanoma.
The receptor-targeted lymphatic mapping agent is marketed by Navidea, a biopharma company based in Dublin, OH.
Identification of lymph nodes in cancer is important because they filter fluid that drains from tissue. If this tissue is cancerous then the fluid will contain cancer cells, and testing lymph nodes - via biopsy - for presence of cancer cells helps determine if the cancer has spread.
The approval of Lymphoseek for use in head and neck cancer patients means doctors will be able to use the agent to guide testing of sentinel nodes - lymph nodes closest to a primary tumor - allowing for the "option of more limited lymph node surgery in patients with sentinel nodes negative for cancer," say the FDA.
Dr. Libero Marzella, director of the Division of Medical Imaging Products in the federal agency's Center for Drug Evaluation and Research, says:

In a clinical trial, researchers found that "Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system."

"For some patients with head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation."
Lymphoseek contains tiny radioactive molecules that are designed to bind to receptors found in high concentrations on the surface of cells located in lymph nodes.
To use Lymphoseek, the doctor injects it into the tumor area and uses a handheld gamma counter to find the sentinel lymph nodes that have taken up the radioactive molecules.
For this new approval, the FDA reviewed a clinical trial that tested Lymphoseek's safety and effectiveness in 85 patients with squamous cell carcinoma of the lip, oral cavity and skin.
The trial - which compared Lymphoseek against conventional tumor location and surgical practice - found that "Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system," notes the FDA announcement.
The trial found that the most common side effects were pain or irritation at the injection site.