Navidea Biopharmaceuticals, Inc. (NAVB) announced the publication of results from two Phase 3 clinical trials of Lymphoseek Injection in patients with breast cancer. The trials assessed the performance of Lymphoseek against the standard of care, vital blue dye, in lymphatic mapping. Lymphoseek met its primary efficacy endpoint of rate of agreement, or concordance, with vital blue dye.
Lymphoseek is a receptor-targeted radiopharmaceutical recently approved by the U.S. FDA and indicated for use in lymphatic mapping for breast cancer and melanoma. In this procedure key lymph nodes adjacent to a primary tumor, that may contain tumor metastases, are identified and biopsied to determine if cancer has spread to these lymph nodes.
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