The U.S. Food and Drug Administration has approved a new use for Lymphseek Injection, in helping physicians to determine the severity of  squamous cell carcinoma, a type of cancer, has spread in the body’s head and neck region.

Lymphoseek is a radioactive diagnostic imaging agent that helps to identify lymph nodes nearest to a primary tumor in individuals with melanoma or breast cancer. Lymphatic fluid that flows from various body tissues is filtered through the lymph nodes. Cancer cells may linger in this fluid, particularly if it drains from an area of the body where a tumor exists. By conducting a biopsy, physicians can often detect metastasis of cancers.

Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, is optimistic about the impact of this newly approved injectable agent.

“For some patients with head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation. To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find the sentinel lymph nodes that have taken up Lymphoseek’s radioactivity,” said Marzella in a statement.

Lymphoseek can now be used by doctors to test lymph nodes for cancer, referred to as a “sentinel” lymph node biopsy, in cancer patients with tumors in the head and neck region. This will offer the option of more limited lymph node surgery in patients with sentinel nodes negative for cancer.

Navidea Biopharmaceuticals, Inc. markets Lymphoseek.