The FDA has approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region.
Last year the agency signed off on using Lymphoseek to help identify lymph nodes closest to a primary tumor in patients with breast cancer or melanoma. Lymph nodes filter lymphatic fluid circulating the body’s tissues, which may or may not contain cancer cells, depending on whether the fluid drains an area of the body that has a tumor. This is usually determined through a biopsy of the lymph nodes.
With last week’s approval, doctors can now use Lymphoseek to “guide testing of lymph nodes closest to a primary tumor for cancer, called a ‘sentinel’ lymph node biopsy, in patients with cancer of the head and neck. stated Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research.“For some patients with head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation,” he added.
To do this 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 most common side effects identified in clinical trial was pain or irritation at the injection site.