Navidea announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors and the addition of sentinel lymph node detection for breast cancer and melanoma to the approved indications.
Lymphoseek is the only approved radiopharmaceutical agent for sentinel lymph node detection and for lymphatic mapping of solid tumors.
The FDA has also expanded the use of Lymphoseek with or without lymphoscintigraphy, to enable pre-operative imaging and mapping of lymph nodes to aid node localization during surgical procedures.
The approval is supported by a combined analysis of prospective Phase 3 trials in melanoma, breast cancer, and certain head and neck cancers from more than 500 patients. The analysis from all 3 studies showed positive diagnostic ability of Lymphoseek across the solid tumor types studied. Lymphoseek accurately identified lymph nodes for assessment in the trial patients, and was likely to be predictive of node pathology status.
For more information call (800) 793-0079 or visit Lymphoseek.com.