Radiopharmaceutical developer Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA).
Navidea is seeking approval to market its Lymphoseek imaging agent for the detection of sentinel lymph nodes in patients with head and neck cancer, an indication for which Lymphoseek was granted fast-track designation earlier this month. If the sNDA is approved, Lymphoseek would be the only approved agent for detecting sentinel lymph nodes in this patient population, according to the firm.
Lymphoseek is currently approved for use in lymphatic mapping procedures that are performed to aid the diagnostic evaluation of potential cancer metastasis in patients with breast cancer and melanoma.
