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The U.S. Food and Drug Administration has approved a new indication for Lymphoseek (technetium 99m tilmanocept) injection-a radioactive diagnostic imaging agent-to be used to guide sentinel lymph node testing for patients with head and neck cancers to help determine the extent that squamous cell carcinoma has spread in patients in the head and neck regions.

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The new indication will allow for the option of more limited lymph node surgery in patients for whom cancer is not found in sentinel nodes.


Lymphoseek, marketed by Navidea Biopharmceuticals, Inc., was first approved in 2013 to help identify lymph nodes closest to a primary tumor in patients with breast cancer or melanoma (OT 4/10/13 issue).


"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 a news 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."


The safety and effectiveness for the new indication were established in a clinical trial of 85 patients with squamous cell carcinoma of the lip, oral cavity, and skin. All patients were injected with Lymphoseek. Surgeons then removed suspected lymph nodes-those identified by Lymphoseek and those identified by tumor location and surgical practice. Pathologic examination showed that Lymphoseek-guided sentinel node biopsy accurately determined if the cancer had spread through the lymphatic system.


The most common side effect reported in the trial was pain or irritation at the injection site.