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FDA grants orphan drug status to Lymphoseek for head and neck cancers
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The FDA granted orphan drug designation to the radioactive diagnostic imaging agent technetium 99m tilmanocept for sentinel lymph node detection in patients with cancer of the head and neck, its manufacturer announced recently.
Technetium 99m tilmanocept (Lymphoseek, Navidea Biopharmaceuticals) — approved last year to guide lymphatic mapping in patients with melanoma and breast cancer — aids in the localization of lymph nodes that drain a primary tumor site.
The FDA based its decision in part on preclinical research, including an estimated 40,000 procedures being performed in this patient population.
“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,” Michael Goldberg, MD, interim CEO of Navidea, said in a press release. “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.”
The FDA Office of Orphan Products grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.