Navidea announced that it has submitted a Supplemental New Drug Application (sNDA) to the FDA seeking approval for Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node (SLN) detection in patients with head and neck cancer. Earlier this month, Lymphoseek was granted Fast Track designation for this indication.
The sNDA submission was based on data from the Phase 3 trial NEO3-06, a prospective, open-label, multicenter, within-patient study. It was designed to identify sentinel lymph nodes 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 (lymph nodes found to harbor cancer) following a multiple level lymph node dissection, and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease.
Results demonstrated that Lymphoseek correctly identified 38 out of 39 patients, for an overall FNR of 2.56%, which met the predefined statistical threshold. These findings indicate that Lymphoseek accurately identified SLNs in these trial subjects, and is likely to be predictive of overall node pathology status. Moreover, multiple level nodal dissection of patients in the trial with cancer-positive lymph nodes led to an average removal of 38 lymph nodes per patient, whereas Lymphoseek on average led to the removal of approximately 4 lymph nodes, representing a substantial reduction in potential morbidity for patients with head and neck cancer undergoing single lymph node biopsy.
Navidea also provided study results that demonstrated the ability of Lymphoseek to detect SLNs in same-day or subsequent-day surgery following injection, as well as being used in lymph node imaging, or lymphoscintigraphy.
Lymphoseek, a receptor-targeted, small-molecule radiopharmaceutical, 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.
For more information call (800) 476-5270 or visit Lymphoseek.com.