Navidea submits Lymphoseek application to EMA

Radiopharmaceutical developer Navidea Biopharmaceuticals has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its investigational radiopharmaceutical Lymphoseek injection, an intraoperative lymphatic mapping agent.

The application proposes the use of Lymphoseek (technetium-99m tilmanocept) in general lymphatic mapping, not restricted to any particular solid tumor type. It is supported by a clinical program that includes results from two phase III studies performed in patients with either breast cancer or melanoma, according to Navidea.

Navidea is also seeking marketing approval of Lymphoseek in the U.S., the company said.

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