FDA Approves Pixclara (Floretyrosine F 18), First-Ever FET-PET Imaging Agent for Distinguishing Recurrent Glioma From Treatment Effect

The FDA approved Telix Pharmaceuticals' Pixclara (floretyrosine F 18), the first FDA-approved FET-PET imaging agent, indicated to differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients 1 month and older, used alongside other diagnostic evaluations. The radiotracer targets L-type amino acid transporters (LAT1/LAT2), which are upregulated in tumor tissue, using a fluorine-18 label. FET-PET has long been recommended in NCCN and international glioma guidelines as the preferred method for distinguishing true tumor progression from pseudo-progression or radiation necrosis, but no FDA-approved agent existed in the US prior to this approval — clinicians relied on off-label or investigational tracers. Roughly 24,000 new glioma cases are diagnosed in the US annually; the most common adverse reaction was headache (0.5% of patients). Pixclara is also in a Phase 3 registrational study for potential expansion into brain metastases imaging.