Lymphoseek Receives FDA Approval For Diagnosis of HNSCC

The FDA has approved the diagnostic agent technetium 99m tilmanocept for the detection of the spread of head and neck cancers.

The U.S. Food and Drug Administration today 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.

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 that flows from the body’s tissues. This fluid 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, a procedure called a biopsy, doctors can sometimes determine if a cancer has spread.

With today’s approval, Lymphoseek can now be used 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. This new indication will allow for the option of more limited lymph node surgery in patients with sentinel nodes negative for cancer.

Source: FDA