FDA grants expanded use for Lymphoseek

Lymphoseek is now approved by the Food and Drug Administration to help clinicians determine whether squamous cell carcinoma has spread to a patient’s head and neck region.

Lymphoseek (technetium 99m tilmanocept injection, Navidea Biopharmaceuticals) was approved in 2013 for use in identifying lymph nodes closest to primary tumors in patients with melanoma or breast cancer. The newest FDA approval allows clinicians to use Lymphoseek to guide sentinel lymph node biopsy in patients who have squamous cell carcinoma of the oral cavity. It is the only FDA-approved radiopharmaceutical application for sentinel lymph node detection, according to a news release.

“Lymphoseek … will be immediately available with the existing reimbursement codes for this expanded population of cancer patients,” Michael Goldberg, M.D., Navidea’s interim chief executive officer, said in the statement.

The expanded approval came after a prospective phase 3 study demonstrated that Lymphoseek had a statistically significant ability to correctly identify patients with pathology-positive lymph nodes compared to multiple level lymph node dissection and pathology assessment, according to the company.