FDA approve Lymphoseek to evaluate head and neck cancer

Date: Jun-16-2014The 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.

In March 2014, Medical News Today reported how a commonly used mood-stabilizing drug could reduce risk

of head and neck cancer. Writing in the journal Cancer, researchers describe how

individuals who took valproic acid - normally used to treat epilepsy and manic-depressive illness,

such as bipolar disorder - for at least a year had a 34% lower risk of developing head and neck

cancer, compared with those who did not use the medication.

Written by Catharine Paddock PhD

View all articles written by Catharine, or follow Catharine on:

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.