JUN 03, 2016 08:46 AM PDT

FDA Clears New Diagnostic Agent for Detection of Rare Tumors

WRITTEN BY: Xuan Pham
After earning priority review status, the French-based pharmaceutical company Advanced Accelerator Applications just received FDA approval for a new agent to image neuroendocrine tumors (NET). Marketed under the name Netspot, the kit prepares a radioactive agent that helps doctors spot and treat the rare tumors. Outside of the U.S. Netspot is known as Somakit-TATE.

"Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical," said Libero Marzella, director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research. "Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor. This information is important for planning the appropriate course of therapy."

Neuroendocrine tumors (NETs) form from abnormal neuroendocrine cells, which are hormone cells found throughout the body, especially in the lungs, stomach and intestines. This tumor type is rare, but still affects over 47,000 people in the US and European Union annually. Sometimes benign but sometimes cancerous, the tumor can lurk undetected for years and delay diagnosis and treatment. Thus with surgery, chemotherapy, and/or radiotherapy interventions, the five-year survival rate still hovers between 50 to 60 percent.
 

Netspot is a diagnostic solution to detecting NETs. The single-dose kit prepares a radioactive substance, known as gallium Ga 68 dotatate, as an injectable. This radioconjugate has the capacity to bind to somatostatin receptors that are present on the hormone-producing NETs. Then, positron emission tomography (PET) imaging reveals the locations of these tumors. Uptake of the Ga 68 dotatate also reveals the density of the tumors. From a chemical affinity perspective, Ga 68 dotatate binds to the somatostatin receptors much stronger than the body’s somatostatin hormone. This allows for clear and accurate visualization of the tumors, if they are present.

The new intervention has already undergone three clinical trials, in which its safety and efficacy was stringently tested. In one of the trials, the company compared Netspot against standard imaging techniques and demonstrated that Netspot performed better. They reported no adverse reactions from Netspot.

Following the approval, the company plans to make Netspot available to doctors as soon as possible. They note that although NETs are designated as rare tumors, otherwise called an “orphan disease,” the incidence of this tumor has grown over 500 percent over the past 30 years. As such, making better diagnostic tools available for the detection of these tumors can yield better outcome for the patients involved.

Additional source: Advanced Accelerator Applications press release
About the Author
  • I am a human geneticist, passionate about telling stories to make science more engaging and approachable. Find more of my writing at the Hopkins BioMedical Odyssey blog and at TheGeneTwist.com.
You May Also Like
OCT 17, 2019
Microbiology
OCT 17, 2019
A Canine Cancer That Began to Spread From One Dog About 6,000 Years Ago
Dogs can get different kinds of cancers, including one that is transmitted by live cancer cells, which spread through sexual contact....
OCT 17, 2019
Cancer
OCT 17, 2019
Eat more flavonoids!
An apple a day keeps the doctor away? New research published in Nature Communications suggests that there might be some truth to that old saying. But it&rs...
OCT 17, 2019
Cardiology
OCT 17, 2019
Childhood Cancer Survivors Prone to Cardiac Events
A new study published in the American Heart Association's journal Circulation explores the relationship between childhood cancer, metabolic conditions ...
OCT 17, 2019
Cardiology
OCT 17, 2019
Exercise Produces Greater Benefits In Those With Cardiovascular Disease
The fact that exercise benefits the heart and can help a person live a longer healthier life is well established. Exercising regularly can improve quality...
OCT 17, 2019
Cancer
OCT 17, 2019
Handheld device detects skin cancer
I can’t be the only one who has ever looked at a suspicious freckle and wondered, “Could this be skin cancer?” Of course, when 9,500 Amer...
OCT 17, 2019
Cancer
OCT 17, 2019
Blood test to predict prostate cancer
A study published recently in the Journal of Urology details the results from a new type of blood test that is capable of diagnosing prostate cancer. The i...
Loading Comments...