Download FDA approves Lymphoseek to help locate lymph nodes in patients

FDA News Release
FDA approves Lymphoseek to help locate
lymph nodes in patients with certain
cancers
For Immediate Release
March 13, 2013
The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc
99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors
locate lymph nodes in patients with breast cancer or melanoma who are undergoing
surgery to remove tumor-draining lymph nodes.
Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may
contain cancer cells, especially if the fluid drains a part of the body containing a tumor.
By surgically removing and examining the lymph nodes that drain a tumor, doctors can
sometimes determine if a cancer has spread.
Lymphoseek is an imaging drug that helps locate lymph nodes; it is not a cancer
imaging drug. Lymphoseek is the first new drug used for lymph node mapping to be
approved in more than 30 years. Other FDA-approved drugs used for lymph node
mapping include sulfur colloid (1974) and isosulfan blue (1981).
“Removal and pathological examination of lymph nodes draining a primary tumor is an
important diagnostic evaluation for some patients with breast cancer or melanoma,” said
Shaw Chen, M.D., deputy director of the Office of Drug Evaluation IV in the FDA’s
Center for Drug Evaluation and Research. “To use Lymphoseek, doctors inject the drug
into the tumor area and later, using a handheld radiation detector, find lymph nodes that
have taken up Lymphoseek’s radioactivity.”
Lymphoseek’s safety and effectiveness were established in two clinical trials of 332
patients with melanoma or breast cancer. All patients were injected with Lymphoseek
and blue dye, another drug used to help locate lymph nodes.
Surgeons subsequently removed suspected lymph nodes for pathologic examination.
Confirmed lymph nodes were examined for their content of blue dye and/or
Lymphoseek. Results showed Lymphoseek and blue dye had localized most lymph
nodes, although a notable number of nodes were localized only by Lymphoseek.
The most common side effects identified in clinical trials was pain or irritation at the
injection site.
Lymphoseek is marketed by Navidea Biopharmaceuticals, Inc. based in Dublin, Ohio.
For more information:
FDA Approved Drugs: Questions and Answers
FDA: Drug Innovation
Media Inquiries: Stephanie Yao, 301-796-0394, [email protected]
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The
agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm343525.htm
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