Pixclara (floretyrosine F 18): FDA approval, pivotal trial and safety
Approved
Type
Diagnostic agent · Intravenous
FDA-approved use
To use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluationsWording from FDA's list of novel approvals.
FDA review
Priority reviewOrphan drug
Company
Telix
Application
NDA 218592
Specialty
Oncology, Radiology
At a glance
Pixclara (floretyrosine F 18) is a radioactive PET imaging agent approved September 11, 2026 to help distinguish recurrent or progressive glioma from treatment-related change, alongside other diagnostic evaluations, in adults and children 1 month and older. The label text provided describes the pivotal study designs but does not include efficacy results, so no effect size can be reported here. There is no boxed warning; the main points are the risk of image misinterpretation and radiation exposure.
What it is and how it works
Floretyrosine F 18 is a radiolabeled tyrosine derivative. It is a substrate for the large neutral amino acid transporters LAT1 and LAT2, which are highly expressed in glioma tissue and at the blood-brain barrier. The agent accumulates in cells that carry these transporters, and the fluorine-18 label allows PET imaging. It is an amino acid PET tracer, which differs from MRI-based assessment alone.
Prospective, single-center, open-label study with PET/MR imaging of the brain. Three independent nuclear medicine experts read the PET images blinded to other clinical and imaging data, except non-contrast T1 MR images used for localization. Readers labeled up to five lesions each as tumor or treatment-related change. A multidisciplinary panel set the composite reference standard using MRI up to 6 months after PET, histopathology, other imaging, and clinical and surgical reports. The panel did not see the PET images or reader assessments.
Patients
127 patients in the image analysis (116 adults, 7 adolescents aged 12 to 16 years, 4 children aged 5 to 11 years) with suspected recurrent or progressive glioma of any grade after radiation, surgery, or both, and suspected progression or recurrence on MRI. Mean age 48 years; 62% male.
Compared with
No comparator drug. PET reads were compared with the composite reference standard.
Primary endpoint
Accuracy of blinded PET reads in classifying lesions as tumor or treatment-related change, against the reference standard. The label excerpt does not state the specific end points.
Result
Not provided in the label excerpt.
Other results
Not provided in the label excerpt.
Safety in the trial
Pooled safety across the program is described in the safety section; headache was the most common adverse reaction.
How does Pixclara (floretyrosine F 18) compare with the alternatives (Contrast-enhanced MRI, Advanced MRI (perfusion or spectroscopy), Other amino acid PET tracers) for its approved use (to use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluations)? Summarize head-to-head and indirect evidence, efficacy, safety and where each fits, with citations.
Ask in EvidencePulseOpens in a new tab. Nothing is sent until you press Ask. Free to try, more with 2MM+.
Deep research is a core feature of 2MM Max.
Study 2
Design
Blinded central read study of retrospectively collected images from multicenter, real-world clinical practice.
Patients
Not described in the label excerpt.
Compared with
No comparator drug described in the excerpt.
Primary endpoint
Differentiation of recurrent or progressive glioma from treatment-related change. Specific end points are not given in the excerpt.
There is no boxed warning. Image misinterpretation can occur: a negative scan does not rule out recurrent or progressive glioma, and a positive scan does not confirm it. Equivocal findings, such as low-level or atypical uptake, may lead to false positive or false negative reads. Results should be correlated with histopathology, cross-sectional imaging, and clinical history. Each dose adds to cumulative radiation exposure, which is linked to higher cancer risk, so safe handling is needed. Patients should hydrate and void often after administration. Headache was the most commonly reported adverse reaction (incidence at least 0.5%). Safety was evaluated in 382 patients with glioma.
What it competes with
Suspected glioma recurrence is usually assessed with contrast MRI, often with advanced MRI techniques, and confirmed by tissue sampling when needed. Other PET tracers are also used in practice.
Contrast-enhanced MRIFirst-line imaging for follow-up of treated glioma, but it can struggle to separate tumor from treatment-related change.
Advanced MRI (perfusion or spectroscopy)Adds physiologic information to standard MRI to help with the same question, with variable performance.
Other amino acid PET tracersRadiolabeled amino acid agents used in some centers for glioma imaging, with differing availability.
Biopsy or repeat surgeryGives tissue diagnosis but is invasive and may be limited by tumor location and sampling error.
Bottom line for clinicians
Pixclara is for patients with a treated glioma in whom MRI cannot separate tumor recurrence or progression from treatment effect, including children 1 month and older. Weigh it as an adjunct, not a stand-alone test, given the risk of false positive and false negative reads. Efficacy results were not in the material provided, so check the full label before deciding how much weight to give a scan result.
Dosing, contraindications and full warnings are in the prescribing information.
New FDA approvals in your inbox
The free 2 Minute Medicine Daily Brief: new approvals, landmark trials and the day's top studies, written by physicians.
Your subscription opens securely in a new tab.
Last updated October 28, 2026 by 2 Minute Medicine.
For healthcare professionals. A summary of public FDA documents and published trials, not medical advice. Check the full prescribing information before prescribing.
Get the app