(By Balaseshan) Navidea Biopharmaceuticals Inc. (NYSEAMEX: NAVB) said it has submitted Marketing Authorization Application (MAA) for intraoperative lymphatic mapping agent Lymphoseek injection in Europe.
The company has submitted a MAA for its investigational radiopharmaceutical Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel intraoperative lymphatic mapping (ILM) agent, to the European Medicines Agency (EMA).
Navidea is seeking marketing approval for Lymphoseek in the European Union for use in ILM, a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes.
The Lymphoseek MAA has proposed the use of the agent in general lymphatic mapping not restricted to any particular solid tumor type. According to the European Union's FACT Public Health Programme Fighting Against Cancer, about 2.2 million new cases of solid tumor type cancers are expected to be diagnosed in the EU.
Lymphoseek injection is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancers such as breast cancer and melanoma.
Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor.
The Marketing Authorization Application submission is supported by a comprehensive clinical program including the results from two Phase 3 studies of Lymphoseek, NEO3-05 and NEO3-09, performed in patients with either breast cancer or melanoma. The primary endpoint for both the NEO3-05 and NEO3-09 studies was the concordance (or the rate of agreement) on a lymph node count basis of Lymphoseek with vital blue dye.
NAVB is trading down 1.02% at $2.90 on Tuesday. The stock has been trading between $2.14 and $4.77 for the past 52 weeks.