Lymphoseek Approved for Diagnosing Cancer Severity
Imaging agent helps determine if squamous cell has spread to head and neck
FRIDAY, June 13, 2014 (HealthDay News) -- U.S. Food and Drug Administration approval for the Lymphoseek imaging agent (technetium 99m tilmanocept) has been expanded to include helping doctors determine if a type of cancer called squamous cell carcinoma has spread to the head and neck, and to what extent, the FDA said Friday.
The injected agent was first approved in 2013 to help doctors identify lymph nodes associated with breast cancer or melanoma skin cancer, the agency said in a news release.
For the newly approved use, the agent was evaluated in clinical study of 85 people with squamous cell carcinoma of the lip, mouth or skin. The most common side effects noted were injection-site pain and irritation.
Lymphoseek is marketed by Navidea Biopharmaceuticals, based in Dublin, Ohio.
The FDA has more about this approval (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm401085.htm ).