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UPDATE: Navidea Biopharma Announces Positive Lymphoseek Injection Results

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Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced results
from combined analyses of Phase 3 clinical trials that evaluated Lymphoseek^®
efficacy in lymphatic mapping for identifying pathology-positive lymph nodes
across multiple solid tumor types: melanoma, breast cancer and head and neck
squamous cell carcinoma. The results indicated that Lymphoseek sensitivity for
sentinel lymph node mapping was consistent across the tumor type studies,
regardless of whether surgery was conducted on the same day as, or on the day
after injection of Lymphoseek. Additionally, for patients with head and neck
cancer, Lymphoseek demonstrated a low false negative rate (FNR) of 2.6% (4.6%
for same day injection before surgery and 0.0% FNR in patients injected the
day prior to surgery). Results from the study comprise part of an sNDA filing
for Lymphoseek which is under review by the U.S. Food and Drug Administration.

“Flexibility and the ability to predictably image and schedule lymphatic
mapping procedures either the day before or on the same day of surgery enable
efficient and economical utilization of staff and healthcare resources,” said
James O'Donnell, M.D., Division Chief, Nuclear Medicine, UH Case Medical
Center, Cleveland, Ohio. “The convenience of receptor-targeted imaging agents
such as Lymphoseek, which can provide diagnostic accuracy, rapid injection
site clearance and predictable lymph node uptake, facilitate lymphatic mapping
and informed diagnostic evaluation by clinicians for patients who may have
breast cancer, melanoma or head and neck cancer.”

“These results clearly demonstrate the clinical adaptability and utility of
Lymphoseek in sentinel lymph node lymphatic mapping to reliably identify
tumor-draining lymph nodes that may be at high risk of harboring cancer in
patients with breast cancer, melanoma or head and neck squamous cell
carcinoma,” said Cornelia Reininger, M.D., Ph.D., Senior Vice President and
Chief Medical Officer of Navidea. “Our sNDA for Lymphoseek use in sentinel
node biopsy in patients with head and neck cancer, based in part on this
study, is in Priority Review with the FDA with an approaching PDUFA date of
June 16, 2014. Results from this study are also included in a second sNDA for
Lymphoseek label expansion currently in review with the FDA, which is designed
to support more flexible utilization of Lymphoseek in lymphatic mapping and
lymphoscintigraphy imaging. These applications reflect Navidea's commitment to
expanding usage and indications for Lymphoseek and our belief that the product
can provide a flexible, reliable and cost-effective solution for lymphatic
mapping across a wide range of tumor types.”

The study evaluated Lymphoseek sensitivity in 384 evaluable patients from
three pivotal Phase 3 clinical studies: two Phase 3 studies in patients with
breast cancer and melanoma (melanoma, n=153; breast cancer, n=148) and one
Phase 3 study in patients with head and neck squamous cell carcinoma (n=83).
Patients were injected before surgery, imaged, and then surgery was conducted
up to 30 hours post-injection. Results based on sensitivity for
day-of-injection or day-after-injection were compared. Meta-analysis results
across tumor types (n=100 pathology-positive patients) indicated per patient
sensitivity for Lymphoseek in identifying pathology-positive subjects.
Sensitivity for Lymphoseek was 99% in same day injection procedures, and 99%
in surgery procedures performed the day after injection. In addition, the FNR
for patients with head and neck squamous cell carcinoma was 4.6% (95% CI:
0.1%-22.8%) for same day injection (n=40) and 0.000 (95% CI: 0%-20.6%) for
patients who had surgery on the day after injection (n=42). The data were
presented by Bonnie Abbruzzese, Director, Clinical Research, MS, RD, CCRA,
Navidea Biopharmaceuticals, at the 2014 Annual Meeting of the Society of
Nuclear Medicine and Molecular Imaging (SNMMI) in St. Louis, Mo.

Posted-In: News FDA Press Releases

 

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