Navidea Biopharmaceuticals, Inc, recently announced that technetium 99m tilmanocept (Lymphoseek Injection) has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation is based upon an estimated 40,000 procedures being performed in this patient population. The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose, or prevent rare, diseases and disorders.
Tilmanocept is a novel receptor-targeted lymphatic mapping agent used in the evaluation of lymphatic basins that may have cancer involvement in patients with breast cancer, melanoma, and head and neck cancer patients with oral cavity carcinoma. The agent is currently approved by the FDA for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. ■