FDA Approves Lymphoseek for Head and Neck Cancer Lymphatic Mapping

Key Insights

• The FDA has approved Navidea Biopharmaceuticals' Lymphoseek for sentinel lymph node biopsy guidance in head and neck cancer patients with squamous cell carcinoma of the oral cavity.
• Lymphoseek, a radioactive diagnostic imaging agent, was initially approved in 2013 for locating lymph nodes in breast cancer and melanoma patients.
• This expanded indication marks the second approval for Lymphoseek in the U.S., broadening its clinical utility in cancer staging.

The FDA has granted approval for Navidea Biopharmaceuticals' Lymphoseek injection for expanded use in guiding sentinel lymph node (SLN) biopsy for patients with head and neck cancer, specifically squamous cell carcinoma of the oral cavity. This marks the second indication for Lymphoseek in the United States, potentially improving staging and surgical planning for these patients.

Lymphoseek, a radioactive diagnostic imaging agent, was initially approved by the FDA in March 2013 for identifying lymph nodes in patients with breast cancer or melanoma undergoing sentinel lymph node biopsy. The agent is designed to be injected and then tracked using imaging to locate the sentinel lymph nodes, which are the first nodes to which cancer cells are likely to spread.

Commercialization and Distribution

Lymphoseek was launched in the U.S. in May 2013, with Navidea partnering with Cardinal Health for its sale and distribution. Navidea began reporting revenue from Lymphoseek in the second quarter of 2013. In Q2 2013, Navidea's share of product revenue from Lymphoseek sales was $128,000, followed by $144,000 in Q3 2013, $343,000 in Q4 2013, and $627,000 in Q1 2014.

Additional Regulatory Filings

Navidea had an additional Supplemental New Drug Application under review by the FDA, seeking approval for more flexible and extended utilization practices of Lymphoseek, with a decision date set for October 16, 2014.