Navidea's Lymphoseek meets clinical trial goals for new indication
Navidea Biopharmaceuticals announced that a Phase III trial of Lymphoseek, its technetium Tc-99m tilmanocept imaging agent, met study goals in terms of sensitivity, negative predictive value and overall accuracy of nonsentinel lymph node diagnosis in assessment of cancer in the head or mouth. The company may submit a supplemental new drug application by the end of the year based on the positive study results.
Note: On March 13, 2013, the US FDA approved Lymphoseek® (technetium Tc 99m tilmanocept) Injection for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.
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