Lymphoseek Injection Receives Expanded Indication for Head and Neck Cancer SLN Biopsy

August 2014, Vol 5, No 6 - FDA Approvals, News & Updates


The FDA approved technetium Tc 99m tilmanocept (Lymphoseek In­jection; Navidea Biopharmaceuticals) for an expanded use for guiding sentinel lymph node (SLN) biopsy in patients with head and neck cancers with squamous-cell carcinoma of the oral cavity. This is the first approval for a radiopharmaceutical agent for the diagnosis of SLN. The approval was done under the agency’s priority review process.

In 2013, the FDA approved Tc 99m for lymphatic mapping in patients with breast cancer or with melanoma. The new indication was approved based on data from a prospective phase 3 study showing that Tc 99m had a significantly greater ability to correctly identify patients with pathology-positive SLN compared with lymph node dissections or pathologic evaluations.

In addition, the use of multiple levels of lymph node dissection in the trial resulted in the removal of 38 lymph nodes per patient compared with only 4 lymph nodes, on average, with Tc 99m, which represents a substantial reduction in potential morbidity in patients undergoing SLN biopsy. (June 13, 2014)