The FDA orphan drug status is based upon an estimated 40,000 procedures being performed in patients with these cancers.
Navidea Interim CEO Michael Goldberg said 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 the company’s competitive position by providing seven years of market exclusivity in this indication.
"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," Goldberg said.
Lymphoseek Injection, a novel, receptor-targeted, small-molecule radiopharmaceutical, is the first and only FDA-approved receptor-targeted lymphatic mapping agent.
It is used to assess lymphatic basins that may have cancer involvement in patients with breast cancer, melanoma and head and neck cancer patients with oral cavity carcinoma.
The injection is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.