Orphan status for Navidea’s Lymphoseek in head and neck cancers

US biotech company Navidea Biopharmaceuticals (NYSE MKT: NAVB) that its Lymphoseek (technetium Tc 99m tilmanocept) Injection has been granted Orphan Drug Designation by the US Food and Drug Administration for use in sentinel lymph node detection in patients with cancer of the head and neck.

The designation is based on an estimated 40,000 procedures being performed in this patient population. The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

“This Orphan Drug designation provides further validation of Lymphoseek for sentinel lymph node detection, underscores the need for new innovations in the treatment of patients with head and neck cancer, and, importantly strengthens Navidea’s competitive position by providing seven years of market exclusivity in this indication," said Michael Goldberg, Navidea interim chief executive. "This decision follows the FDA Fast Track designation, Priority Review and subsequent sNDA approval of Lymphoseek for guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity,” he noted.