The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' 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.
The company said that 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.
The expanded approval from FDA is supported by data from the company’s NEO3-06 prospective Phase III trial that showed with statistical significance the ability of Lymphoseek to correctly identify patients with pathology-positive lymph nodes compared with multiple level lymph node dissection and pathology assessment.
The data show that Lymphoseek accurately identified SLNs in the trial subjects for assessment, and is likely to be predictive of overall node pathology status.
In addition, multiple level nodal dissections 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 would have led to the removal of about four lymph nodes, reducing potential morbidity for patients with head and neck cancer undergoing sentinel lymph node biopsy.
Navidea interim chief executive officer Michael Goldberg said with this approval, Lymphoseek is now the only FDA-approved diagnostic agent with a label for guiding sentinel lymph node biopsy procedures and will be immediately available with the existing reimbursement codes for this expanded population of cancer patients.
"Navidea intends to continue its investment in Lymphoseek to further expand its use in other types of cancer, where current alternatives are neither efficient nor effective," Goldberg said.
"We believe Lymphoseek can play a critical role in the staging and treatment of cancer, with potential for additional procedural cost savings."