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news.The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' supplemental new drug application (sNDA) for the expanded use of Lymphoseek injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications.
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Lymphoseek (technetium Tc 99m tilmanocept) is now indicated for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
It helps in guiding Sentinel Lymph Node Biopsy (SLNB) using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity, breast cancer or melanoma.
In order to allow pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures, the FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging, known as lymphoscintigraphy.
The company said that lymphoseek is the first and only FDA-approved radiopharmaceutical agent for sentinel lymph node detection and the only FDA-approved agent for lymphatic mapping of solid tumors.
Lymphoseek will be immediately available using existing reimbursement codes for this expanded population of cancer patients.
The expanded approval is based on data from the company’s combined analysis of Lymphoseek’s pivotal prospective Phase III data in melanoma, breast cancer, and certain head and neck cancers from over 500 subjects.
Navidea interim chief executive officer Michael Goldberg said Lymphoseek is the now the only agent approved by the FDA for lymphatic mapping across solid tumors when used as a component of surgical management.
"This significantly expands the potential market for Lymphoseek and materially enhances the company’s ability to promote the use of Lymphoseek in solid tumor cancers where assessment of lymphatic involvement is critical to properly staging the disease, especially colorectal, gynecological, lung and prostate cancers," Goldberg said.