The US Food and Drug Administration (FDA) has approved Telix Pharmaceuticals’ Pixclara (floretyrosine F 18, or 18F-FET), which Telix says makes it the first FDA-approved fluorine-18-labelled amino acid positron emission tomography (FET-PET) imaging drug for glioma.
The intravenous radiopharmaceutical is indicated for use with PET to help differentiate recurrent or progressive glioma from treatment-related changes in adults and children aged one month and older, alongside other diagnostic evaluations.
Why this matters
The approval addresses a significant unmet need in brain cancer imaging.
Following treatment, changes seen on conventional scans can make it difficult to determine whether a glioma is progressing or whether the findings are treatment-related, with this uncertainty complicating decisions on subsequent treatment.
FET-PET imaging is already recommended in international clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Guidelines.
However, until now, no FET-PET imaging product has received FDA approval for use in the US.
According to Telix, approximately 24,000 new cases of glioma are diagnosed in the US each year.
Gliomas account for around 30% of brain and central nervous system tumours and approximately 80% of malignant brain tumours.
Radiopharmaceutical targets amino acid transporters
Pixclara combines a small-molecule targeting compound with the diagnostic radioisotope fluorine-18.
Following intravenous administration, the compound targets L-type amino acid transporters 1 and 2 (LAT1 and LAT2), which are expressed in glioma tissue.
The fluorine-18 label emits radiation that can be detected using PET, generating imaging data that can complement other diagnostic assessments.
For Telix, this new FDA approval also expands its precision medicine and theranostics platform beyond prostate cancer into brain cancer.
The company develops radiopharmaceutical diagnostics alongside targeted radiopharmaceutical therapies, aiming to pair disease-specific imaging with treatment.
This includes TLX101-Tx (131I-iodofalan), an investigational targeted radiopharmaceutical being evaluated in the Phase III IPAX-2 trial programme for recurrent glioblastoma.
Unlike Pixclara, TLX101-Tx has not received marketing authorisation in any jurisdiction.
Pixclara itself is also being evaluated in a Phase III registrational study for a potential indication expansion into the diagnosis of brain metastases.
Kevin Richardson, CEO of Telix Precision Medicine, said the approval would enable broader US access to FET-PET imaging and give physicians greater certainty in diagnosis.
As the first FDA-approved PET imaging drug for glioma, Pixclara will provide physicians in the US with more certainty in their diagnoses and greater confidence in their treatment planning for patients.
The FDA decision therefore represents not only a milestone for glioma imaging but also an expansion of radiopharmaceuticals' role across the brain cancer treatment pathway, from diagnosis and monitoring through to potential targeted therapy.
