- Lymphoseek is first and only FDA-approved sentinel lymph node biopsy agent for use in head and neck cancer patients with oral cavity carcinoma -

- Lymphoseek now available for multiple patient populations using existing reimbursement codes -

- Company to Host Conference Call on Monday, June 16, 2014, 8:30 a.m. EDT -
DUBLIN OHIO -- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek® (technetium Tc 99m tilmanocept) Injection indicated for guiding sentinel lymph node (SLN) biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity.

Lymphoseek becomes the first and only FDA-approved radiopharmaceutical application for sentinel lymph node detection and was first approved in March 2013 for lymphatic mapping in breast cancer and melanoma patients.

"In the current standard of care for certain head and neck tumors, such as oral cavity cancers, as many as 30 or more lymph nodes may be removed during a surgical procedure. While sentinel lymph node mapping may be an effective alternative to elective neck dissection, adoption of this approach has been slow in the U.S. because of the lack of an FDA-approved agent with favorable characteristics for use in the head and neck region," said Stephen Y. Lai, M.D., Ph.D., FACS, Associate Professor, Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center. "This underscores the urgent need Lymphoseek may be able to address in improving the precision of SLN mapping and decreasing nodal excision to an average of only four lymph nodes. As a result, Lymphoseek offers the potential to more effectively stage certain cancers, direct post-surgical treatment and decrease patient morbidity."

"Our community eagerly welcomes a diagnostic aid such as Lymphoseek that may allow for a less invasive surgical procedure for patients with oral, head, and neck cancers," said Nancy Leupold, Founder & President of Support for People with Oral, Head, and Neck Cancer. "According to the National Cancer Institute, oral, head, and neck cancers account for approximately three percent of all malignancies in the United States, however, post-procedural side effects are more severe than with many other types of cancer. Significant changes in a patient's facial and neck appearance may be present. In addition, a patient may have difficulty with chewing, swallowing, smelling, tasting, speaking and hearing in addition to dental problems."

More HCB News