Lymphoseek gets FDA orphan drug designation for head and neck cancers

Navidea, based in Dublin, Ohio, announced yesterday that the radiopharmaceutical company has received orphan drug designation for the small molecular radiotracer technetium-99m tilmanocept (Lymphoseek) specifically for sentinel lymph node mapping in cancer cases of the head and neck.

The company noted that the designation was contingent on about 40,000 procedures that were conducted in patients with head and neck cancers. The FDA orphan drug designation is designed to promote drugs that demonstrate value for relatively rare diseases that affect fewer than 200,000 people in the U.S.

“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 Navidea Interim CEO, Michael Goldberg, MD, in a press release.

This designation comes swiftly after a recent supplemental new drug application approval for Lymphoseek in cases of squamous cell carcinoma of the oral cavity.

The designation also affords Navidea a seven-year period of marketing exclusivity in head and neck cancers, and other advantages, such as certain waived filing fees, additional tax credits, federal grants and the option to have filing fees of up to $1.1 million refunded.