FDA OKs Lymphoseek for Head and Neck Cancer

Larry Hand


June 13, 2014

The US Food and Drug Administration (FDA) has approved technetium 99m tilmanocept (Lymphoseek, Navidea Biopharmaceuticals) injection for identification of sentinel lymph nodes for head and neck cancer.

The radioactive diagnostic imaging agent was originally approved in 2013 to help identify lymph nodes nearest primary tumors for breast or skin cancer.

The new use gives physicians the option to perform less extensive lymph node surgery if a patient's sentinel nodes are negative for cancer.

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

Researchers established Lymphoseek's safety and effectiveness in a clinical trial involving 85 patients with squamous cell carcinoma of the lip, oral cavity, and skin.

After patients were injected with the diagnostic agent, surgeons removed suspected lymph nodes for pathologic examination and determined whether the cancer had spread through the lymphatic system.

Results showed that the Lymphoseek-guided sentinel lymph node biopsy accurately determined whether the cancer had spread through the lymphatic system, according to the FDA.

Researchers identified pain or irritation at the injection site as the most common adverse effects during the clinical trial.

Most head and neck cancers start in the squamous cells lining the moist surfaces inside the head and neck, according to the National Cancer Institute. Alcohol and tobacco use, as well as human papillomavirus infection, are risk factors for head and neck cancer.


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