The Food and Drug Administration has approved the use of Lymphoseek, a radioactive diagnostic imaging agent, to aid in the diagnosis of head and neck cancers known as squamous cell carcinomas. It is classified as a lymphatic mapping agent. Lymphoseek had already been approved in March by the FDA for use in mapping breast cancer and melanoma metastatices.
Lymphoseek is injected into the body and helps doctors identify lymph nodes nearest to primary tumors. A biopsy of these lymph nodes can then detect the presence of metastatic cancer cells.
Lymph nodes filter fluid that drains from tissue. They are a common route of transmission for cancer cells that spread from the primary tumor site to new sites. Lymphoseek will help doctors will be able to more accurately test sentinel nodes - lymph nodes closest to a primary tumor - which will prevent the unnecessary removal of lymph nodes that test negative.
"For some patients with head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation. To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find the sentinel lymph nodes that have taken up Lymphoseek's radioactivity." said FDA director of the Division of Medical Imaging Products Libero Marzella.
The main benefit Lymphoseek will provide is in guiding therapy and treatment options. It will help doctors focus in on a more targeted area for treatment and reduce risk of recurrence and improve patient prognosis.
Lymphoseek was developed by Dublin, Ohio-based Navidea Biopharmaceuticals. President and CEO of Navidea Mark J. Pykett stressed the importance of the agent in the fight against cancer.
"We believe today's approval of Lymphoseek validates our ability to advance the field of precision diagnostics. Our vision is to improve diagnostic accuracy, clinical decision-making and patient care. We are gratified that our scientific achievements may benefit thousands of patients diagnosed with breast cancer and melanoma each year," he said.
During the original approval process, over 540 subjects received Lymphoseek. Later studies were conducted in patients with either breast cancer or melanoma. In this phase Lymphoseek was detectable in 97 percent of lymph nodes.
During the approval process Lymphoseek was evaluated in a clinical study of 85 patients with squamous cell carcinomas of the lip, mouth or skin.
The company claims no clinically significant drug-related adverse reactions have been reported yet, with no contraindications and only injection-site irritation.
Lymphoseek will be sold and distributed in the U.S. by Cardinal Health.