GE Healthcare gains FDA approval for diagnostic imaging agent for detecting neuroendocrine tumours
GE Healthcare (NYSE:GE) has gained US FDA approval for AdreView (Iobenguane I 123 Injection), a molecular imaging agent for the detection of rare neuroendocrine tumours in children and adults. It provides high quality images that allow physicians to detect tumours, both at the time of initial diagnosis and at later examinations when relapse or recurrence is suspected.
“AdreView will have an immediate impact on improving diagnostic assessment of pediatric cancer patients with neuroblastoma,” said Dr. Arnold Jacobson, MD, PhD, GE’s clinical project leader for the AdreView program. “AdreView also will provide reliable imaging data to aid in identifying primary and metastatic pheochromocytoma, a predominantly adult tumour that often presents diagnostic challenges for clinicians. The introduction of AdreView is a reflection of our commitment to provide new and improved molecular imaging solutions for physicians and their patients.”
Neuroblastoma is the most common extra-cranial solid tumour of young children up to 5 years of age, while pheochromocytoma is a rare tumour typically affecting adults. Both tumours usually arise from tissues of the sympathetic nervous system, most commonly in the adrenal glands.
Neuroblastoma and pheochromocytoma can be difficult to detect at an early stage because symptoms may be non-specific when the tumours are small. AdreView images reflect the functional behaviour of the tumour cells, thus allowing clearer characterization of even small tumours in comparison to similar appearing but non-malignant tissues. AdreView provides valuable adjunctive information to complement anatomic imaging procedures such as CT and MRI.
GE Healthcare expects to begin supplying the imaging agent to hospitals and imaging centres throughout the United States in the coming weeks.
AdreView will also permit imaging of these tumours with a lower radiation dose than other agents that have been available for this purpose. It can be used with single photon emission computed tomography (SPECT) imaging, a valuable addition for localizing sites of disease in the body.
“AdreView is just the first of many new products we are developing to deliver on the promise of molecular medicine,” said Don Black, MD, vice-president of research and development for GE Healthcare’s Medical Diagnostics business. “We are invested in making imaging agents that will make new medical breakthroughs a reality.”