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Lymphoseek Injections Approved by FDA for Prolonged Extended Use
- Updated: June 14, 2014
Navidea Biopharmaceuticals, Inc., Ohio has received permission by the U.S FDA to extend the use of the injection Lymphoseek. Doctors use this imaging agency to diagnose and determine the level of spread of cancer in the neck and head region of patients. The medical term for this type of cancer is “squamous cell carcinoma” These types of cancers start in the cells that are moist and located inside the neck and head. By surgically removing the lymph nodes that drain the tumor through a biopsy, the doctors can tell if the cancer has spread.
Alcohol and tobacco abuse are generally the cause for contracting this type of cancer in the head and neck. Initially Lymphoseek (technetium 99m tilmanocept) was used to identify lymph nodes that were in proximity with breast cancer patients. However, now doctors can use this radioactive imaging agent to check the sentinel lymph node which is a primary tumor for patients with cancer of the neck and head. Patients will not have to undergo unnecessary surgery when detecting this type of cancer if the sentinel nodes are non-cancerous. A pathological examination is carried out to determine the extent of spread throughout the lymphatic system.
Doctors use the handheld detector when searching for the sentinel lymph nodes while injecting the drug into the area where the tumor is present. They find it easier to determine if the lymphatic system is affected by cancer or not. Studies carried out on 85 people in a clinic indicated that the side effects commonly reported were irritation and pain at the injection-site.
Navidea has succeeded in getting the 1st and only radiopharmaceutical application approved by the FDA and now seeks approval for an additional application for a Supplemental New Drug and this is being currently reviewed by the FDA. The decision is expected to be made on October 16, 2014.