(By Balachander) Navidea Biopharmaceuticals Inc.'s (NYSEAMEX: NAVB) imaging drug - Lymphoseek injection - for lymph node mapping has been approved by the U.S. health regulators.
Lymphoseek, a radioactive diagnostic imaging agent, helps doctors locate lymph nodes in patients with breast cancer or melanoma.
The U.S. Food and Drug Administration (FDA) said Lymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years.
"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," the FDA said.
[Related -Navidea (NAVB) Submits Lymphoseek Marketing Authorization Application In Europe]
In two clinical trials patients were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes. Results showed Lymphoseek and blue dye had localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek, the FDA said.
The FDA noted that most common side effects identified in clinical trials was pain or irritation at the injection site.
Dublin, Ohio-based Navidea's Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
According to the American Cancer Society, approximately 229,000 new cases of breast cancer and 76,000 new cases of melanoma are expected to be diagnosed in the United States in 2012.
The stock, which has been trading in the 52-week range of $2.14 to $4.77, retreated 5.57 percent to trade at $3.22 at 11.42 am ET on Wednesday.