FDA Sanctioned Lymphoseek To Help Determine Spread of Cancer in Head and Neck Region

The federal regulators have approved a new injection, 'Lymphoseek', to determine the extent of spread of cancer in the head and neck.

Navidea's Lymphossek received the green signal from the U.S. Food and Drug Administration to help health care professionals determine the extent of the spread of squamous cell carcinoma in the  head and neck region. Lymphoseek (technetium 99m tilmanocpet) injection is a radioactive diagnostic imaging agent.

Prior to this in the year 2013, Lymphoseek was available to help detect lymph nodes, which  are closest to the primary tumor in those with breast cancer or melanoma.  These lymph nodes filter lymphatic fluid that flows through the body tissues and this fluid may have cancer cells. On surgically removing these lymph nodes and doing a biopsy, the doctors can easily determine whether or not the cancer has spread.

But with this latest approval, Lymphoseek can be used to test lymph nodes that are closest to the primary tumor for cancer through the  sentinel lymph node biopsy .

"For some patients with head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation," said Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research. "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."

The safety and effectiveness of Lymphoseek was established in a clinical trial that included 85 patients who were diagnosed with squamous cell carcinoma of the lip, oral cavity and skin. These patients were injected with Lymphoseek. The suspected lymph nodes were removed for pathology examination.  On analyzing the results the researchers noticed that Lymphoseek helped accurately determine whether or not cancer had spread through the lymphatic system.

Those injected with Lymphoseek experienced some common side effects like pain or irritation at the injection site.