FDA Accepts sNDA for Review for Lymphoseek Label Expansion

Navidea announced that the FDA has accepted for review an additional supplemental New Drug Application (sNDA) for the proposed expanded label for Lymphoseek (technetium 99m tilmanocept) Injection to support broader and more flexible use in imaging and lymphatic mapping procedure, including lymphoscintigraphy and other optimization capabilities.

The two Lymphoseek sNDAs are derived from a single application submitted to FDA in December 2013. The FDA chose to separate the filing in two based on the proposed labeling extensions requested and the scope of information provided.. The first sNDA, aimed at Lymphoseek's use as a sentinel lymph node detection agent in patients with head and neck cancer. This second sNDA application is aimed at expanding the Lymphoseek label to support more flexible utilization practices for Lymphoseek in lymphatic mapping and lymphoscintigraphy imaging.

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The submission was based on data from a series of prospective, controlled Phase 3 studies in patients with breast cancer, head and neck cancer, and melanoma. These study results demonstrated the ability of Lymphoseek to detect lymph nodes in same-day or subsequent-day surgery following injection, as well as being used in lymph node imaging, or lymphoscintigraphy.

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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