Komen Funded Early Trials of Lymphoseek® Approved Today
DALLAS – March 13, 2013 – Leaders of Susan G. Komen for the Cure, the world’s largest breast cancer research organization, applauded the U.S. Food and Drug Administration’s (FDA) approval today of a new diagnostic tool, called Lymphoseek®, that can more accurately determine whether breast cancer has spread to lymph nodes, helping to avoid overtreatment of women and men with the disease.
“The ability to more accurately track cancer’s spread will help doctors treat breast cancer more effectively, without the likelihood of removing unaffected lymph nodes,” said Chandini Portteus, vice president of Research, Evaluation and Scientific Programs for Komen. “This will help to ensure that women and men with breast cancer are getting the right treatment for their disease, as early as possible. We are very pleased to have played an early role in the development of this tool.”
Komen funded a 1999, $231,000 grant to Dr. Anne Wallace of the University of California, San Diego, for a Phase I clinical trial that tested the safety of Lymphoseek®. The FDA’s approval of Lymphoseek means that this new diagnostic tool can replace the standard blue dye used today, which can miss up to 25 percent of cancer cell-containing lymph nodes.
Lymphoseek contains a radioactive molecule that is targeted specifically to lymph nodes. When injected, it allows doctors to visualize and identify the lymph nodes that have the highest probability of harboring cancer. The procedure is used to determine if cancer has spread beyond the primary tumor and aids in the staging process. Accurate staging of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence.
More information on the science behind Lymphoseek® can be found here.
Komen currently is funding more than $300 million in research grants worldwide, and is the largest non-profit funder of breast cancer research outside of the Federal government, with more than $750 million invested in breast cancer research since Komen’s founding in 1982.