National Brain Tumor Society (NBTS) welcomes the U.S. Food and Drug Administration’s (FDA) approval of floretyrosine F 18 (Pixclara), developed by Telix Pharmaceuticals. It is the first FDA-approved PET imaging agent for glioma. The approved indication is to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and children one month of age and older.
The following is a statement from David Arons, President and Chief Executive Officer of NBTS:
“Following treatment, an area that lights up on a traditional MRI scan will often indicate that a tumor has continued or resumed growing. In a significant number of cases, though, it might actually be an indication of treatment-related changes such as necrosis – or dead tissue – from radiation or an inflammatory response to treatment, known as pseudoprogression. These can look virtually identical to tumor progression on traditional MRI scans. Because of this, patients with glioma and their families often live with an additional and unique form of ‘scanxiety’ – the uncertainty and apprehension that accompany the watch-and-wait periods familiar to many people affected by cancer – while not knowing what is actually happening inside their tumor.
“Advanced imaging agents, technologies, and techniques offer the potential for added clarity for both clinicians and patients in neuro-oncology as they work to determine whether what shows up on a scan means the tumor is back or the treatment is working, and plan subsequent therapy accordingly. Yet amino acid PET imaging, including FET-PET, has been recommended in international clinical practice guidelines and used by neuro-oncologists across Europe for years without being readily available to patients in the United States.
“While contrast-enhanced MRI, and in many cases perfusion MRI, will remain central to brain tumor monitoring, FET-PET imaging like Pixclara provides a different kind of information that a care team can weigh alongside those results. That is reflected in the approved indication itself, which specifies use in conjunction with other diagnostic evaluations. Used in this complementary way, this approval gives clinicians in the United States a meaningful new tool to help patients make potentially better-informed treatment decisions.
“We’re hopeful that this approval – and the fact that fluorine-18 is relatively easy to ship and dispose of – will allow most medical centers with a nuclear medicine department and PET scanner to soon offer FET-PET to patients with gliomas in instances where additional imaging could be beneficial in determining treatment response.
“NBTS commends all those involved in advancing this imaging agent, including Telix Pharmaceuticals, the researchers and clinicians who studied it, and, most importantly, the patients and families who took part in the studies that made this approval possible.”
About the National Brain Tumor Society
Building on over 30 years of experience, the National Brain Tumor Society (NBTS) unrelentingly invests in, mobilizes, and unites the brain tumor community to discover a cure, deliver effective treatments, and advocate for patients and caregivers. Our focus on defeating brain tumors and improving the quality of patients’ lives is powered by our partnerships across the science, health care, policy, and business sectors. We fund treatments-focused research and convene those most critical to curing brain tumors — once and for all. Join us at BrainTumor.org.
