Author: press release
Navidea announced that the FDA has granted Fast Track designation to Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer. Lymphoseek Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
Lymposeek Injection was evaluated in a prospective, open-label, multicenter, within-patient study (NEO3-06). It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes following a multiple level lymph node dissection. A minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease was required. Thirty nine subjects out of over 80 subjects enrolled were determined to have pathology-positive lymph nodes.
Navidea intends to file the supplemental New Drug Application (sNDA) for Lymphoseek before the end of 2013. Lymphoseek is already approved for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.