FDA Approves Extended Use of Lymphoseek

FDA Approves Extended Use of Lymphoseek

Today, the U. S. Food and Drug Administration has given permission for the extended use of Lymphoseek (technetium 99m tilmanocept) Injection. It is a radioactive diagnostic imaging agent being used by doctors to determine the level at which a type of cancer has spread in the body's head and neck region. It is marketed by Navidea Biopharmaceuticals, Inc. based in Dublin, Ohio.

In 2013, Lymphoseek was approved to help doctors identify lymph nodes in proximity with a primary tumor in patients with breast cancer.

With today's approval, Lymphoseek can now be also used to assist doctors in testing of lymph nodes closest to a primary tumor for cancer called sentinel lymph node biopsy in patients having cancer of head and neck.

The surgery will reduce the unnecessary surgeries in patients with sentinel nodes testing negative for cancer. Libero Marzella, Director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research, was of the view, "For some patients with head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation".

To use Lymphoseek, doctors inject the drug into the tumor area. With the use of a handheld radiation detector, the search for the sentinel lymph nodes that have taken up a Lymphoseek's radioactivity becomes easier.

To be used for this new indication, Lymphoseek's safety as well as efficacy was checked in a clinical trial of 85 patients having squamous cell carcinoma of the lip, oral cavity, and skin. All the patients were injected with Lymphoseek.

Researchers removed suspected lymph nodes, the ones identified with Lymphoseek and the ones based on tumor location and surgical practice. It was found that Lymphoseek-guided lymph node biopsy was able to correctly determine whether the cancer had spread through the lymphatic system or not.


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