Navidea Biopharmaceuticals has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for its Lymphoseek injection, designed for the detection of sentinel lymph node (SLN) in patients with head and neck cancer.
The sNDA submission follows the FDA approval and the US launch of Lymphoseek for use in lymphatic mapping procedures that are carried out to aid in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.
Earlier this month, the FDA also granted fast-track designation to Lymphoseek for head and neck cancer.
Navidea CEO Mark Pykett said the sNDA submission for Lymphoseek will help patients who generally face extensive surgery to properly stage their cancer.
"If this sNDA is approved, Lymphoseek will be the only approved agent for SLN detection in this patient population, and representing another step forward in Navidea’s efforts to develop precision diagnostics that improve the accuracy of diagnosis," Pykett said.
The filing is based on data secured from the prospective, open-label, multicentre, within-patient NEO3-06 Phase III trial that showed with statistical significance the ability of Lymphoseek to correctly identify patients with pathology-positive lymph nodes compared with this assessment using multiple level lymph node dissection and pathology assessment, the current gold standard.
The Phase III NEO3-06 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 in 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.
The company said that FNR is the rate of occurrence of negative test results in subjects known to have the disease they are being tested for.
Out of the more than 80 subjects enrolled in the NEO3-06 trial, 39 were determined to have pathology-positive lymph nodes.
Results of the trial showed that Lymphoseek correctly identified 38 of the 39 patients, for an overall FNR of 2.56%, which met the predefined statistical threshold and the findings specify that Lymphoseek accurately identified SLNs in these trial subjects, and is likely to be predictive of overall node pathology status.
Image: Left inferior internal jugular node metastases with extranodal invasion, two years after brachytherapy of tongue cancer. Photo: courtesy of Akira Kouchiyama.