Navidea announced that the Food and Drug Administration (FDA) has granted Lymphoseek (technetium Tc 99m tilmanocept) injection an Orphan Drug Designation for use in sentinel lymph node detection in patients with head and neck cancer.

The Orphan Drug Designation is following Lymphoseek’s Fast Track Designation, Priority Review, and subsequent supplemental New Drug Application (sNDA) approval of Lymphoseek for guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity.

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Lymphoseek is a novel receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients with breast cancer, melanoma, and head and neck cancer patients with oral cavity carcinoma.

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