The US Food and Drug Administration (FDA) has accepted Navidea Biopharmaceuticals’ supplemental new drug application (sNDA) and granted a priority review for the expanded use of Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node (SLN) detection in patients with head and neck cancer.
The FDA has set a target review date for the Lymphoseek sNDA of 16 June 2014, under the Prescription Drug User Fee Act (PDUFA).
Currently, the small-molecule radiopharmaceutical Lymphoseek is approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumour in patients with breast cancer and melanoma.
Navidea CEO Mark Pykett said: "If this sNDA is approved, Lymphoseek will be the only FDA-approved diagnostic agent with SLN detection claims, and represents another step forward in Navidea’s efforts to develop precision diagnostics that improve the accuracy of diagnosis."
The sNDA submission is based on data secured from the NEO3-06 Phase III study that showed with statistical significance the ability of Lymphoseek to correctly identify patients with pathology-positive lymph nodes compared with multiple level lymph node dissection and pathology assessment, the current ‘gold standard’.
The prospective, open-label, multicentre, within-patient Phase III trial 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 trial was based on the number of subjects with pathology-positive lymph nodes following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease.
Of the more than 80 subjects enrolled in the trial, 39 subjects were determined to have pathology-positive lymph nodes.
Results showed that Lymphoseek correctly identified 38 of these 39 patients, for an overall FNR of 2.56%, which met the predefined statistical threshold.
The US FDA previously granted fast-track designation for Lymphoseek for its sNDA for sentinel lymph node detection in patients with head and neck cancer.
Navidea plans to expand the development of Lymphoseek into other solid tumour areas that may include head and neck cancers, prostate cancer, thyroid cancer, lung/bronchus cancers, colorectal cancer and others.
Lymphoseek Injection is a lymphatic mapping agent indicated for use with a hand-held gamma counter to assist in the localisation of lymph nodes draining a primary tumour site in patients with breast cancer or melanoma.