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

PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
Nuclear imaging scan showing very good tissue delineation. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Nuclear imaging scan showing very good tissue delineation. It offers crisp overall image quality and sharply delineates the muscle and fat planes, vertebral margins and end plates, billiary radicals, renal calyces, aortic wall and papillary muscles of the heart. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Technology | PET-CT | June 05, 2018
June 5, 2018 — The U.S.
Emerging Trends in Nuclear Medicine
Feature | Nuclear Imaging | June 04, 2018 | By Jeff Zagoudis
Nuclear imaging and its various modalities have long played an important role in the diagnosis and treatment of numer
PET Imaging Agent Could Provide Early Diagnosis of Rheumatoid Arthritis

Coronal 18F-FEDAC PET/CT section of a mouse with collagen-induced arthritis. (A) On day 23 and day 37, increased uptake is noted in the front and hind paws of this mouse with collagen-induced arthritis. (B) Predictive performance of day 23 18F-FEDAC uptake for the development of clinical arthritis. ROC = receiver operating characteristic; Sn = sensitivity; Sp = specificity. Credit: Seoul National University and Ewha Womans University, Seoul, South Korea

News | PET Imaging | May 17, 2018
A novel positron emission tomography (PET) tracer developed by Korean researchers can visualize joint inflammation and...
PET Imaging Shows Protein Clumping May Contribute to Heart Failure Development
News | PET Imaging | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
News | Radiopharmaceuticals and Tracers | May 09, 2018
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in...
Novel PET Agent Could Help Guide Therapy for Brain Diseases

Rat brain 11C‐Me‐NB1 PET images (0‐60 min) superimposed on an MRI template. Credit: SD Krämer et al., ETH Zurich, Zurich, Switzerland

News | PET Imaging | April 10, 2018
Researchers have developed a new imaging agent that could help guide and assess treatments for people with various...
The Chalk River nuclear reactor license has been renewed, but will be decommissioned by 2028.

The Chalk River nuclear isotope reactor license has been renewed, but will be decommissioned by 2028. The reactor supplies about 50 percent of the world's supply of Tc99m.

Feature | Nuclear Imaging | April 02, 2018 | Dave Fornell
April 2, 2018 – The Canadian Nuclear Safety Commission (CNSC) announced March 29 that it renewed Canadian Nuclear Lab
The yellow in the anterolateral entorhinal cortex of the young brain indicates significant activity, something that is absent in the older brain.

This figure shows two different brains that are aligned to a common template space for comparison. The yellow in the anterolateral entorhinal cortex of the young brain indicates significant activity, something that is absent in the older brain. CREDIT: Zachariah Reagh

News | Nuclear Imaging | March 08, 2018
As we get older, it's not uncommon to experience "senior moments," in which we forget where we parked our car or call...
Overlay Init