Priority Review Given for the Expanded Use of Lymphoseek (Technetium-99m Tilmanocept) Injection
Navidea Biopharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has accepted the Supplemental New Drug Application (sNDA) and granted a Priority Review for the expanded use of Lymphoseek (Technetium-99m tilmanocept) Injection indicated for sentinel lymph node (SLN) detection in patients with head and neck cancer.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a June 16 target review date for the Lymphoseek sNDA. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
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