FDA approve Lymphoseek to evaluate head and neck cancer
Source: www.medicalnewstoday.com Author: Catharine Paddock PhD The US Food and Drug Administration have given the OK for doctors to use Lymphoseek - a radioactive diagnostic imaging agent - to evaluate the spread of squamous cell carcinoma in the body's head and neck region. Lymphoseek (technetium 99m tilmanocept) Injection was approved by the Food and Drug Administration (FDA) in 2013 to help doctors identify lymph nodes closest to primary tumors in patients with breast cancer and melanoma. The receptor-targeted lymphatic mapping agent is marketed by Navidea, a biopharma company based in Dublin, OH. Identification of lymph nodes in cancer is important because they filter fluid that drains from tissue. If this tissue is cancerous then the fluid will contain cancer cells, and testing lymph nodes - via biopsy - for presence of cancer cells helps determine if the cancer has spread. The approval of Lymphoseek for use in head and neck cancer patients means doctors will be able to use the agent to guide testing of sentinel nodes - lymph nodes closest to a primary tumor - allowing for the "option of more limited lymph node surgery in patients with sentinel nodes negative for cancer," say the FDA. In a clinical trial, researchers found that "Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system." Dr. Libero Marzella, director of the Division of Medical Imaging Products in the federal agency's Center for Drug Evaluation and Research, says: "For some patients with head and [...]