FDA Approves Navidea's Lymphoseek For Head And Neck Cancer

The U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Navidea Biopharmaceutical’s Lymphoseek (technetium 99m tilmanocept) Injection as aradioactive diagnostic imaging agent used to identify the extent of squamous cell carcinoma metastasis in the head and neck region.

Lymphoseek received FDA approval in 2013 to help doctors determine the lymph nodes in greatest proximity to a primary tumor in patients with melanoma or breast cancer. The company submitted regulatory filing for Lymphoseek as a sentinel lymph node biopsy agent in head and neck cancer with squamous cell carcinoma. The new approval allows the use of Lymphoseek as an option for more limited lymph node surgery in patients with sentinel nodes negative for cancer.

Libero Marzella, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research (CDER), said, “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.”

According to the National Cancer Institute, head and neck cancers are responsible for around 3% of all cancer in the U.S. The cancer type has the most severe post-procedural side effects of most cancers. Affected patients may experience difficulty with chewing, swallowing, speaking, and hearing in addition to dental problems.

Stephen Y. Lai, Associate Professor of the Department of Head and Neck Surgery at The University of Texas MD Anderson Cancer Center, said that current care standards for some head and neck tumors require as many as 30 or more lymph nodes to be surgically removed for biopsy, whereas Lymphoseek requires the excision of an average of only 4 lymph nodes. “While sentinel lymph node mapping may be an effective alternative to elective neck dissection, adoption of this approach has been slow in the U.S. because of the lack of an FDA-approved agent with favorable characteristics for use in the head and neck region… As a result, Lymphoseek offers the potential to more effectively stage certain cancers, direct post-surgical treatment and decrease patient morbidity.”

The approval was based on positive results from a clinical trial of 85 patients with squamous cell carcinoma of the lip, oral cavity, and skin showing that Lymphoseek–guided sentinel lymph node biopsy accurately determined if cancer had spread through the patients’ lymphatic system.