Research update

FDA approves Pixclara

The first FDA-approved FET-PET imaging drug for glioma

The U.S. Food and Drug Administration has approved Pixclara® (floretyrosine F 18, also called 18F-FET), an amino acid positron emission tomography imaging drug for glioma.

Pixclara is the first FDA-approved FET-PET imaging drug for glioma in the United States. According to the approved indication announced by Telix Pharmaceuticals, it is used with PET, alongside other diagnostic evaluations, to help physicians distinguish recurrent or progressive glioma from treatment-related change in adults and children 1 month of age and older.

Why this matters

After treatment for a glioma, changes seen on an MRI are not always straightforward to interpret.

A suspicious area may represent tumor growth or recurrence, but treatment itself can also cause changes that appear abnormal on imaging. Physicians consider the scan together with symptoms, treatment history, other testing, and clinical judgment when determining what may be happening.

FET-PET gives care teams another imaging option that may provide additional information when those changes are difficult to interpret.

For people affected by glioblastoma and other gliomas, the approval expands the brain tumor imaging options available in the United States.

What is FET-PET?

PET, or positron emission tomography, uses a small amount of a radioactive imaging drug, or tracer, to help visualize activity inside the body.

Pixclara contains floretyrosine F 18, commonly referred to as 18F-FET. When used with PET imaging, it can help physicians evaluate areas of concern and distinguish recurrent or progressive glioma from changes that may be related to treatment.

Pixclara is used alongside other diagnostic evaluations rather than on its own.

What this approval does—and does not—mean

Pixclara is a diagnostic imaging drug, not a treatment for glioma.

It does not replace MRI, biopsy when appropriate, clinical assessment, or the judgment of a neuro-oncology team. Instead, it provides another source of information that physicians may consider when evaluating whether a glioma has returned or progressed.

FDA approval also does not necessarily mean Pixclara will immediately be available at every hospital or imaging center. Availability may vary as centers begin offering FET-PET imaging.

Questions patients and care partners can ask

If imaging after treatment is difficult to interpret, patients and care partners may want to ask their medical team:

• What could be causing the changes seen on my MRI?
• Would FET-PET provide useful information in my situation?
• Is Pixclara available at this center or through a referral?
• How would the result affect the next decision in my care?

Whether FET-PET is appropriate will depend on each person’s clinical situation and should be discussed with their medical team.

An important addition to brain tumor imaging

OurBrainBank^® for Glioblastoma welcomes this approval as an important addition to the imaging options available to the brain tumor community.

Clearer information can matter greatly when patients, care partners, and clinicians are making difficult decisions. We will continue sharing practical information as Pixclara becomes available and its use develops across the United States.

This article is for educational purposes only and does not replace medical advice from a qualified healthcare professional.

Source

Telix Pharmaceuticals Limited. “FDA Approves Telix’s Brain Cancer Imaging Drug Pixclara.” September 14, 2026.