News | March 07, 2014

Navidea Announces Acceptance for Review of an Additional sNDA to Further Expand Lymphoseek Labeling

Additional Supplemental New Drug Application for Lymphoseek focuses on more flexible and expanded utilization practices

FDA Review sNDA Navidea Biopharmaceuticals Lymphoseek Injection

March 7, 2014 — Navidea Biopharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review an additional Supplemental New Drug Application (sNDA) for the proposed expanded label for Lymphoseek (technetium 99m tilmanocept) Injection to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target review date for the second Lymphoseek sNDA of Oct. 16, 2014.

The two Lymphoseek sNDAs now accepted are derived from a single, data-rich application submitted to FDA in December 2013. In assessing the application, FDA chose to separate the filing in two based on the proposed labeling extensions requested and the scope of information provided. This second sNDA application is aimed at expanding the Lymphoseek label to support more flexible utilization practices for Lymphoseek in lymphatic mapping and lymphoscintigraphy imaging. The first sNDA, aimed at Lymphoseek’s use as a sentinel lymph node detection agent in patients with head and neck cancer, received FDA Fast Track designation and was accepted for Priority Review, as previously announced, with a PDUFA date target of June 16, 2014. 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 FDA’s decision to review an additional sNDA to further expand Lymphoseek’s labeling underscores our belief that the agent can make a critical difference for patients as part of their overall diagnosis and treatment,” commented Cornelia Reininger, M.D., Ph.D., Navidea’s senior vice president and chief medical officer. “Additionally, the FDA’s decision to grant Priority Review for our first Lymphoseek sNDA focused on sentinel lymph node (SLN) detection in patients with head and neck cancer supports recognition that Lymphoseek-guided SLN detection in this disease can have a significant impact on morbidity. Label expansion for these sNDAs, if approved, may allow for broader cancer-type use, enable more consistent and standardized lymphatic mapping and lymphoscintigraphy analysis, and address important areas of unmet medical need.”

The second Lymphoseek sNDA seeks to expand product claims to enable broader and more flexible utilization of the agent in routine practice, including lymphoscintigraphy imaging and flexible timing of Lymphoseek administration allowing for a 2-day protocol. Data submitted in support of these parameters were derived from Navidea’s series of prospective, well-controlled Phase 3 studies in patients with breast cancer, head and neck cancer, and melanoma. These study results demonstrated the ability of Lymphoseek to detect lymph nodes in same-day or subsequent-day surgery following injection, as well as being used in lymph node imaging, or lymphoscintigraphy.

For more information: www.navidea.com

Related Content

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...
CORAR Supports Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018
News | Radiopharmaceuticals and Tracers | October 12, 2018
October 12, 2018 — The Council on Radionuclides and Radiopharmaceuticals Inc.
PET Imaging Agent Predicts Brain Tau Pathology, Alzheimer's Diagnosis
News | PET Imaging | September 05, 2018
Eli Lilly and Co. and Avid Radiopharmaceuticals Inc. announced a Phase 3 study of positron emission tomography (PET)...
Abnormal Protein Concentrations Found in Brains of Military Personnel With Suspected CTE

Researchers are using the tracer, which is injected into a patient, then seen with a PET scan, to see if it is possible to diagnose chronic traumatic encephalopathy in living patients. In this image, warmer colors indicate a higher concentration of the tracer, which binds to abnormal proteins in the brain. Credit UCLA Health.

News | PET Imaging | August 24, 2018
August 24, 2018 — In a small study of
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...
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...
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...