FDA Approves Lymphoseek for Head and Neck Cancer

June 13, 2014 5:50 PM

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The FDA has approved the radioactive diagnostic imaging agent Lymphoseek (technetium 99m tilmanocept) Injection to guide sentinel lymph node biopsy in patients with cancer of the head and neck.

The approval is based the phase III NEO3-06 clinical trial in which 83 patients with squamous cell carcinoma of the lip, oral cavity, and skin were injected with Lymphoseek. Suspected lymph nodes identified by Lymphoseek and those based on location and surgical practice were removed for pathological...

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