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FDA Approves Lymphoseek to Help Determine Extent of Head-and-Neck Cancer

Diagnostic agent previously approved for use in breast cancer and melanoma

The FDA has approved a new use for Lymphoseek (technetium 99m tilmanocept injection, Navidea Biopharmaceuticals), a radioactive diagnostic imaging agent used to help clinicians determine the extent squamous cell carcinoma has spread in the head-and-neck region.

In 2013, Lymphoseek was approved to help identify lymph nodes closest to a primary tumor in patients with breast cancer or melanoma. Lymph nodes filter lymphatic fluid, which may contain cancer cells, especially if the fluid drains a part of the body containing a tumor. By surgically removing and examining the lymph nodes that drain a tumor, clinicians can sometimes determine whether a cancer has spread.

With the new approval, Lymphoseek can now be used to guide the testing of lymph nodes closest to a primary tumor for cancer — a “sentinel” lymph node biopsy — in patients with cancer of the head and neck. This new indication will allow the option of more limited lymph-node surgery in patients with sentinel nodes negative for cancer, according to the drug’s manufacturer.

“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, MD, PhD, 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.”

For the new indication, the safety and effectiveness of Lymphoseek were established in a clinical study of 85 patients with squamous cell carcinoma of the lip, mouth, or skin. All of the patients were injected with Lymphoseek. Surgeons subsequently removed suspected lymph nodes — those identified by Lymphoseek and those based on tumor location and surgical practice — for pathologic examination. The results showed that Lymphoseek–guided sentinel lymph-node biopsy accurately determined whether the cancer had spread through the lymphatic system.

The most common side effect identified in clinical trials was pain or irritation at the injection site.

Source: FDA; June 13, 2014.

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