Lymphoseek tilmanocept regulatory update

FDA approved an sNDA from Navidea for Lymphoseek tilmanocept expanding its use to include lymphatic mapping in solid tumors and adding sentinel lymph node detection for breast cancer and melanoma. Lymphoseek is now approved in the U.S. for lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which the procedure is a component of intraoperative management and for guiding sentinel lymph node biopsy in patients with clinically node-negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Last month, EMA's CHMP recommended approval of Lymphoseek for sentinel lymph node detection for melanoma, breast cancer or squamous cell carcinoma of the oral cavity. ...