Navidea confirms FDA approval of expanded use for Lymphoseek Navidea Biopharmaceuticals announced that the FDA has approved the Supplemental New Drug Application for the expanded use of Lymphoseek Injection indicated for guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. Lymphoseek becomes the first and only FDA-approved radiopharmaceutical application for sentinel lymph node detection and was first approved in March 2013 for lymphatic mapping in breast cancer and melanoma patients.
Navidea reports data on Lymphoseek vs. Sulfur Colloid in breast cancer Navidea Biopharmaceuticals announced that an analysis comparing sentinel lymph node biopsy procedures using Lymphoseek injection + vital blue dye to filtered sulfur colloid + VBD in breast cancer patients was published in the Annals of Surgical Oncology. Results demonstrated the following: Lymphoseek patients had significantly fewer SLNs removed per procedure; Proportionally fewer nodes were necessary to detect cancer spread; and Nodes removed using Lymphoseek held greater predictive value for diagnosing spread of breast cancer to lymph nodes. The study was published in the January print issue of the journal, Annals of Surgical Oncology.