$NAVB..Navidea Biopharma submits sNDA for Lymphoseek for sentinel lymph node detection in patients with head and neck cancer (NAVB) : Co announces that it has submitted a Supplemental New Drug Application with the FDA seeking approval for the marketing and sale of Lymphoseek Injection for sentinel lymph node detection in patients with head and neck cancer, an indication for which Lymphoseek was also granted Fast Track designation earlier this month. Lymphoseek is currently approved for use in lymphatic mapping procedures that are performed to aid in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.
The sNDA submission is based on previously announced data from the NEO3-06 Phase 3 study that showed with statistical significance the ability of Lymphoseek to correctly identify patients with pathology-positive lymph nodes compared with this assessment using multiple level lymph node dissection and pathology assessment, the current "gold standard". As part of the sNDA submission package, Navidea also provided study results that demonstrated the ability of Lymphoseek to detect SLNs in same-day or subsequent-day surgery following injection, as well as being used in lymph node imaging, or lymphoscintigraphy.
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