The U.S. Food and Drug Administration (FDA) has granted fast-track designation to Navidea Biopharmaceuticals' Lymphoseek (technetium-99m tilmanocept) injection for sentinel lymph node detection in head and neck cancer (HNC).
Navidea intends to file the supplemental new drug application for Lymphoseek before year-end, according to the company. Lymphoseek was approved by the FDA in March 2013 for use in lymphatic mapping procedures that help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.
Fast-track designation facilitates the development and expedites the review of drug candidates intended to treat serious or life-threatening conditions, and those that demonstrate the potential to address unmet medical needs.
Navidea is working with the FDA for an expanded label for Lymphoseek as the first agent indicated in sentinel lymph node detection.
Data from a 2012 phase III clinical trial of Lymphoseek in head and neck and intraoral squamous cell carcinomas (SCCs) suggested that it may be improve surgical treatment of patients with head and neck SCC. Researchers believe this is caused by Lymphoseek's rapid transit through lymphatic vessels and targeted binding to the mannose binding receptors within key predictive nodes. The findings were presented at the American College of Surgeons annual meeting in October.
A potential advantage of Lymphoseek is that substantially fewer lymph nodes are removed than with full nodal dissection, Navidea said. This may enable surgeons to reduce the need for more extensive lymph node dissection, potentially sparing them from the morbidity and side effects of full nodal dissection, while not sacrificing accuracy in detecting key predictive lymph nodes.
