FDA approves Lymphoseek to detect Head and Neck tumours - Navidea Biopharmaceuticals

The FDA has on 13 June 2014 approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection from Navidea Biopharmaceuticals, 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 tumour 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 tumour. By surgically removing and examining the lymph nodes that drain a tumour, a procedure called a biopsy, doctors can sometimes determine if a cancer has spread. With this approval, Lymphoseek can now be used to guide testing of lymph nodes closest to a primary tumour 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.