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

ASNC Announces Multisocietal Cardiac Amyloidosis Imaging Consensus
News | Cardiac Imaging | September 09, 2019
September 9, 2019 — The American Society of Nuclear Cardiology (ASNC) published a new expert consensus document along
A 3-D printed tungsten pre-clinical X-ray system collimator. 3D printed, additive manufacturing for medical imaging.

A 3-D printed tungsten pre-clinical X-ray system collimator. The tungsten alloy powder is printed into the form desired and is laser fused so it can be machined and finished. Previously, making collimators from Tungsten was labor intensive because it required working with sheets of the metal to create the collimator matrix. 

Feature | Medical 3-D Printing | September 04, 2019 | By Steve Jeffery
In ...
A SPECT nuclear scan of the heart to show perfusion defects in the myocardium due to coronary artery blockages or heart attack. The imaging uses the Mo-99 based medical imaging isotope Tc-99m. The U.S. government has created policy to move away from use of highly enriched uranium (HEU) to low-enriched uranium (LEU) for Mo-99 isotope production, but there is one hold out who has not yet converted before a 2020 deadline. Photo courtesy of Philips Healthcare.

A SPECT nuclear scan of the heart to show perfusion defects in the myocardium due to coronary artery blockages or heart attack. The imaging uses the Mo-99 based medical imaging isotope Tc-99m. The U.S. government has created policy to move away from use of highly enriched uranium (HEU) to low-enriched uranium (LEU) for Mo-99 isotope production, but there is one holdout who has not yet converted before a 2020 deadline. Photo courtesy of Philips Healthcare.

Feature | Nuclear Imaging | August 30, 2019 | Dave Fornell, Editor
In a surprising move, the National Institute for Radioelements (IRE) has applied for a new license to export highly e
University of Alabama at Birmingham Leading Production of Theranostic Radioisotope

Image courtesy of the University of Alabama at Birmingham

News | Radiopharmaceuticals and Tracers | August 29, 2019
The University of Alabama at Birmingham, in conjunction with researchers at the University of Wisconsin and Argonne...
United Imaging Announces First U.S. Clinical Installation of uExplorer Total-body PET/CT
News | PET-CT | August 15, 2019
United Imaging announced that its uExplorer total-body positron emission tomography/computed tomography (PET/CT) system...
ASRT Supports Radiopharmaceutical Reimbursement Bill
News | Radiopharmaceuticals and Tracers | August 02, 2019
The American Society of Radiologic Technologists (ASRT) announced its support for House Resolution (HR) 3772, a measure...
International Multidisciplinary Group Publishes Recommendations for Personalized HCC Treatment With Y90 TheraSphere
News | Interventional Radiology | July 31, 2019
New consensus recommendations for personalized treatment for hepatocellular carcinoma (HCC) with BTG’s TheraSphere have...
NorthStar Medical Radioisotopes Awarded $30 Million by U.S. Department of Energy
News | Radiopharmaceuticals and Tracers | July 26, 2019
NorthStar Medical Radioisotopes LLC has been awarded $15 million in a cooperative agreement with the U.S. Department of...
NorthStar Medical Radioisotopes Completes Construction on Beloit, Wis. Molybdenum-99 Processing Facility
News | Radiopharmaceuticals and Tracers | July 16, 2019
NorthStar Medical Radioisotopes LLC  announced completion of construction on its 20,000-square-foot molybdenum-99 (Mo-...
Varian Purchasing Embolic Bead Assets from Boston Scientific
News | Interventional Radiology | July 03, 2019
Varian announced it has signed an asset purchase agreement to acquire the Boston Scientific portfolio of drug-loadable...