Navidea Biopharmaceuticals announced that the European Commission has granted marketing authorization for its Lymphoseek 250-mcg kit for radiopharmaceutical preparation.
Lymphoseek (technetium-99m tilmanocept) is now approved in the European Union (EU) for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity, according to Navidea.
Lymphoseek is approved in the U.S. for use in lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management. It is also approved for guiding sentinel lymph node biopsy using a handheld gamma counter in patients with node-negative squamous cell carcinoma of the oral cavity, breast cancer, or melanoma.
