Published March 15, 2013
WASHINGTON – The Food and Drug Administration has approved a new imaging drug to help doctors locate lymph nodes in patients with breast cancer and skin cancer.
The drug Lymphoseek from Navidea Biopharmaceuticals Inc. is a radioactive imaging agent that is intended to help determine if breast cancer or melanoma has spread to a patient's lymph nodes. By surgically removing lymph nodes that drain from a tumor, doctors can sometimes detect if a cancer has spread from its original site.
Lymphoseek is the first new drug approved to help locate lymph nodes in more than 30 years, according to the FDA. The last drug approved for that use, isosulfan blue, was cleared in 1981.
The FDA approved Lymphoseek based on two studies involving 332 patients with breast cancer or melanoma. Lymphoseek was comparable to an older drug in locating lymph nodes, although a significant number of nodes were only located by Lymphoseek.
The FDA declined to approve the drug in September due to problems with a third-party manufacturer utilized by the company. Navidea said at the time it was working to fix the issues.Navidea Biopharmaceuticals said in a statement the drug will be distributed by Cardinal Health Inc. as part of an agreement between the companies. The Dublin, Ohio, company is still seeking a partner to distribute the drug outside the U.S.