Lymphoseek Approved to Help Locate Lymph Nodes
WEDNESDAY, March 13 -- The injected imaging drug Lymphoseek (technetium Tc 99m tilmanocept) has been approved by the U.S. Food and Drug Administration to help surgeons locate the lymph nodes among people with breast cancer or melanoma.
The lymph nodes filter lymphatic fluid that flows throughout the body. This fluid may contain cancer cells if it has passed through diseased tissue, the FDA said in a news release. By surgically examining the lymph nodes, doctors may be able to conclude if cancer has spread.
Lymphoseek is an imaging drug that helps locate the lymph nodes, but it is not a cancer imaging drug, the agency stressed. It's the first lymph-node mapping drug to be approved by the FDA in 30 years.
The drug's safety and effectiveness were established in clinical trials involving 332 people with melanoma or breast cancer. The most common adverse reactions reported were pain and/or irritation at the injection site.
Lymphoseek is marketed by Navidea Biopharmaceuticals, based in Dublin, Ohio.
The FDA has more about this approval.
Posted: March 2013