FDA Approves New Diagnostic Indication for Lymphoseek

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FDA Approves New Diagnostic Indication for Lymphoseek
FDA Approves New Diagnostic Indication for Lymphoseek

The FDA approved a new indication for Lymphoseek (technetium 99m tilmanocept; Navidea) injection for use in determining the extent of head and neck cancer. This new indication allows Lymphoseek to be used as a guide to sentinel lymph node biopsy in patients with head and neck cancer.

The safety and effectiveness of Lymphoseek were established in a trial of 85 patients with squamous cell carcinoma of the lip, oral cavity, and skin that were all injected with Lymphoseek. Surgeons removed suspected lymph nodes that were identified by Lymphoseek and those that were based upon tumor location and surgical practice. Results showed that Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system.

RELATED: FDA to Review Lymphoseek sNDA in Head and Neck Cancer

Lymphoseek, a receptor-targeted, small-molecule radiopharmaceutical, is already approved for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

For more information call (800) 476-5270 or visit Lymphoseek.com.

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