News | February 28, 2014

Priority Review Given to Expand Lymphoseek Labeling for Sentinel Lymph Node Detection

Navidea Biopharmaceuticals Lymphoseek Nuclear Imaging Radiopharmaceuticals

February 28, 2014 — Navidea Biopharmaceuticals Inc. is a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals. It announced the U.S. Food and Drug Administration (FDA) has accepted the Supplemental New Drug Application (sNDA) and granted a Priority Review for the expanded use of Lymphoseek (technetium 99m tilmanocept) Injection indicated for sentinel lymph node (SLN) detection in patients with head and neck cancer. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a June 16 target review date for the Lymphoseek sNDA. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.

The sNDA submission included data from the NEO3-06 Phase 3 study. That showed statistical significance of Lymphoseek’s ability to correctly identify patients with pathology-positive lymph nodes compared with multiple level lymph node dissection and pathology assessment. The Phase 3 trial NEO3-06 was 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 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 NEO3-06 trial, 39 subjects were determined to have pathology-positive lymph nodes. Results demonstrated that Lymphoseek correctly identified 38 of these 39 patients, for an overall FNR of 2.56 percent, 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.

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. The FDA approved Lymphoseek in March 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. The company anticipates continuing development of Lymphoseek into other solid tumor areas that may include head and neck cancers, prostate cancer, thyroid cancer, lung/bronchus cancers, colorectal cancer and others. 

For more information: www.navidea.com

Related Content

GE Healthcare Recalls Millennium Nuclear Medicine Systems
News | Nuclear Imaging | November 15, 2018
GE Healthcare announced it is recalling its Millennium Nuclear Medicine Systems due to an incident in which the the top...
Artificial Intelligence Predicts Alzheimer's Years Before Diagnosis
News | Neuro Imaging | November 14, 2018
Artificial intelligence (AI) technology improves the ability of brain imaging to predict Alzheimer’s disease, according...
Researchers Awarded 2018 Canon Medical Systems USA/RSNA Research Grants
News | Radiology Imaging | November 13, 2018
The Radiological Society of North America (RSNA) Research & Education (R&E) Foundation recently announced the...
Subtle Medical Showcases Artificial Intelligence for PET, MRI Scans at RSNA 2018
News | Artificial Intelligence | November 13, 2018
At the 2018 Radiological Society of North America annual meeting (RSNA 2018), Nov. 25-30 in Chicago, Subtle Medical...
University of Missouri Research Reactor First U.S. I-131 Supplier in 30 Years

MURR is the only supplier of I 131 in the United States and the first U.S. supplier since the 1980s. Image courtesy of University of Missouri

News | Radiopharmaceuticals and Tracers | November 13, 2018
The University of Missouri Research Reactor (MURR) recently shipped its first batch of Iodine-131 (I-131), a...
MEDraysintell Projects Increasing Mergers and Acquisitions in Nuclear Medicine
News | Nuclear Imaging | November 07, 2018
With the recent announcement by Novartis to acquire Endocyte , interest from the conventional pharmaceutical industry...
Videos | Radiation Oncology | November 06, 2018
Genomics can be used to assess a patient's radiosensitivity, which can be used to increase or decrease the radiation
A PET/CT head and neck cancer scan.

A PET/CT head and neck cancer scan.

Feature | Nuclear Imaging | November 05, 2018 | By Sabyasachi Ghosh
“Experimental validation implemented in real-life situations and not theoretical claims exaggerating small advantages
PET Imaging Offers New Possibilities in Chronic Liver Disease Management

Hepatic 18F-FDG, 18F-FAC, and 18F-DFA accumulation are affected in a mouse model of autoimmune hepatitis. (A) Histochemical and immunohistochemical analyses of liver sections from vehicle- and ConA-treated mice. Scale bars represent 50 microns. Transverse PET/CT images (B) and quantification (C) of vehicle- and ConA-treated mice injected with 18F-FDG, 18F-FAC, and 18FDFA. Livers are outlined in a white dotted line. Quantification represents radiotracer accumulation in the liver normalized to a background organ. Image courtesy of Salas J.R., Chen B.Y., Wong A., et al.

News | PET Imaging | October 24, 2018
While liver biopsies are powerful and reliable, they are also invasive, painful, limited and subject to complications....