Navidea Biopharmaceuticals (Dublin, Ohio) has been given FDA clearance to bring to market its Lymphoseek (Technetium Tc99m Tilmanocept), a radioactive binding agent for identification of lymph nodes around primary breast cancer and melanoma tumors.
Used during intraoperative lymphatic mapping, the agent is injected into a tumor and allowed to go with the flow. As it exits the tumor, it will find itself within sentinel nodes that are typically the next steps in the tumor spreading. A gamma camera is used to detect the distribution of Lymphoseek post injection, the results of which guide physicians regarding which lymph nodes will need to be excised and which to leave alone.
From the announcement:
The approval of Lymphoseek is based on data from more than 540 subjects receiving Lymphoseek. In pivotal Phase 3 studies that were conducted in 332 patients with either breast cancer or melanoma, Lymphoseek, on average, was present in 97% (range 94-100%) of resected, histology-confirmed lymph nodes. To date, no clinically significant drug-related adverse reactions have been reported. Lymphoseek has no contraindications and the most common adverse reactions were injection site irritation and/or pain (<1%).
Lymphoseek will be sold and distributed in the U.S. on an exclusive basis byCardinal Health, Inc. As part of the distribution agreement, Cardinal Health’s Nuclear Pharmacy Services business will be responsible for commercializing and dispensing Lymphoseek to health care professionals who are involved in lymphatic mapping. Navidea is also working to identify and partner with distributors in other markets outside of the U.S.
Product page: Lymphoseek…