Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the approval to market and sale Lymphoseek Injection for sentinel lymph node (SLN) detection in patients with head and neck cancer.
In December 2013, Lymphoseek was also granted FDA fast track status for head and neck cancer.
The filing 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.
Navidea CEO Mark Pykett said the sNDA submission for Lymphoseek is a major step toward the company's goal of helping this patient population 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 submission is based on data from the NEO3-06 Phase III trial that showed the ability of Lymphoseek to correctly identify patients with pathology-positive lymph nodes compared with the assessment using multiple level lymph node dissection and pathology assessment, the current gold standard.
The prospective, open-label, multicenter, within-patient 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.
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.
According to the company, FNR is the rate of occurrence of negative test results in subjects known to have the disease for which they are being tested.
Of the more than 80 subjects enrolled in the NEO3-06 trial, 39 were determined to have pathology-positive lymph nodes.
The results 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 the trial subjects, and is likely to be predictive of overall node pathology status.
