The U.S. FDA has approved an expanded indication for GE Healthcare’s PET imaging agent, Vizamyl (flutemetamol F18 injection), broadening its clinical utility in Alzheimer's disease (AD). The update allows for quantification of amyloid burden in patients with suspected AD and enables the tracer's use in monitoring response to anti-amyloid therapies. This development may enhance neurologists' ability to select appropriate candidates for disease-modifying treatment, track therapeutic effectiveness, and use objective imaging data to guide diagnosis and ongoing care.
Originally approved in 2013, Vizamyl was initially indicated for estimating beta-amyloid (Aβ) neuritic plaque density in adults with cognitive impairment being evaluated for Alzheimer’s.² The latest label expansion now authorizes the use of quantitative amyloid PET imaging across various clinical scenarios, including determining whether amyloid levels have decreased sufficiently to justify stopping treatment.
"The integration of quantitative amyloid PET imaging into routine clinical practice enhances diagnostic accuracy and confidence," said Dr. Phillip Kuo, professor of radiology and nuclear medicine at City of Hope National Medical Center.¹ "This quantitative capability now plays a vital role in guiding initiation and monitoring of amyloid-directed therapies and determining appropriate therapy discontinuation."
The Alzheimer’s treatment landscape has evolved dramatically since Vizamyl’s initial approval. The 2021 approval of aducanumab (Aduhelm; Biogen) marked the entry of the first anti-amyloid therapy targeting both soluble and aggregated Aβ. Subsequently, therapies such as lecanemab (Leqembi; Eisai) and donanemab (Kisulna; Eli Lilly) have entered clinical use, representing a shift from symptom management toward disease-modifying strategies.
While these new agents offer promise, they are associated with high costs and require precise patient selection to maximize benefit. Furthermore, real-world effectiveness remains under scrutiny, particularly in patients with more advanced disease progression.
"The expanded Vizamyl label, which includes quantification and therapy monitoring, is a positive step for clinicians and patients," stated Dr. Jit Saini, chief medical officer of GE Healthcare’s Pharmaceutical Diagnostics division. "These changes support timely, evidence-based care decisions and help bring more personalized treatment options to individuals living with Alzheimer's."
In line with updated Alzheimer's Association diagnostic criteria, the revised label now permits the use of an abnormal amyloid PET scan as sufficient evidence to support an AD diagnosis. It also removes previous restrictions regarding predictive use, acknowledging growing data linking amyloid positivity with higher risk of progression from mild cognitive impairment to dementia.
Vizamyl remains contraindicated in individuals with known hypersensitivity to the agent or its components, including polysorbate 80. The label highlights risks such as radiation exposure (associated with a small increased risk of cancer), and potential for anaphylaxis and other severe allergic reactions. It also cautions against misinterpretation of imaging results. Clinical trials have most commonly reported adverse events including flushing, elevated blood pressure, headache, nausea, and dizziness.