FDA approves first lymph-node mapping drug in 30 years.

The AP (3/14) reports that the US Food and Drug Administration approved Navidea Biopharmaceuticals' "radioactive imaging agent" Lymphoseek (technetium Tc 99m tilmanocept), which is "intended to help determine if breast cancer or melanoma has spread to a patient's lymph nodes." The approval was based on data from two clinical trials, "involving 332 patients with breast cancer or melanoma," that tested the safety of the diagnostic imaging drug, as well its ability to map lymph nodes in comparison to "an older drug." In a statement, announcing the approval, the FDA noted that Lymphoseek is the "first new drug" approved for locating lymph nodes "in more than 30 years." In 1981, the agency approved "isosulfan blue" for lymph node mapping.

        The Columbus (OH) Business First (3/14, Ghose, 11K) notes that Dublin, Ohio-based Navidea, "which started as Neoprobe Corp., has gone through a long saga since licensing Lymphoseek in 2001, at first having the drug approval delayed because of issues with outside companies that make it. The drug will be sold and marketed through a revenue-sharing agreement by Dublin-based Cardinal Health Inc.," which manages the nation's "largest network of pharmacies that specialize in radioactive drugs."

        Medscape (3/14, Chustecka) adds that in the statement, Shaw Chen, MD, Deputy Director of the Office of Drug Evaluation IV in the FDA Center for Drug Evaluation and Research explained that to "use Lymphoseek, doctors inject the drug into the tumor area and then, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek's radioactivity." Medscape also points out that "results from the clinical trial supporting the approval were presented at the annual meeting of the American Society of Clinical Oncology in 2011, and reported at the time by Medscape Medical News."

        Diagnostic Imaging (3/14) reports that during the clinical trials, patients "were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes." Surgeons examined confirmed lymph nodes "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, according to the FDA." Diagnostic Imaging adds that in 1974, the FDA also approved sulfur colloid for lymph-node mapping.