The FDA approved Navidea Biopharmaceuticals’ Lymphoseek radioactive imaging agent, an injectable drug that helps physicians isolate lymph nodes in patients with breast cancer or melanoma.
The Lymphoseek approval marks the 1st time in more than 30 years that the FDA has approved a lymph node mapping drug, according to an agency notice.
"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," the FDA reported. "By surgically removing and examining the lymph nodes that drain a tumor, doctors can sometimes determine if a cancer has spread."
Doctors inject Lymphoseek into a tumor area and later look for traces of the drug in the lymph nodes using a hand-held radiation detector. The most common side effect seen in clinical trials was pain or irritation at the injection site.
"We believe today’s approval of Lymphoseek validates our ability to advance the field of precision diagnostics," Navidea president & CEO Mark Pykett said in prepared remarks. "We look forward to continuing the development of Lymphoseek into additional indications and to progressing our oncology and neurology pipeline."
The company plans to sell Lymphoseek exclusively through Cardinal Health in the U.S. and is looking for distribution partners abroad, according to a press release.