Lymphoseek, a diagnostic imaging agent, has been approved for helping evaluate the spread of squamous cell carcinoma in patients with head and neck cancer, the Food and Drug Administration announced.
In a statement issued on June 13, the FDA said that with this approval, Lymphoseek (technetium 99m tilmanocept) injection "can now be used to guide" sentinel lymph node biopsies in patients with cancer of the head and neck, which "will allow for the option of more limited lymph node surgery in patients with sentinel nodes negative for cancer."
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," Dr. Libero Marzella, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.
This is a new indication for Lymphoseek, marketed by Navidea Biopharmaceuticals. In March 2013, it was approved for assisting in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.
Approval of the new indication is based on a study that used Lymphoseek in the evaluation of 85 patents with squamous cell carcinoma of the lip, oral cavity, and skin, which "showed that Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system," according to the FDA. Pain and irritation at the injection site were the most common adverse effects associated with Lymphoseek in the study.