The FDA has approved Telix Pharmaceuticals' floretyrosine F18 (Pixclara), making it the first FET-PET imaging agent approved in the US for glioma. Indicated for adults and children aged 1 month or older, the agent helps differentiate recurrent glioma from treatment-related changes. The approval follows a March 2026 resubmission after an initial April 2025 rejection. Clinical trials with 381 patients showed 66%-83% agreement with experts on disease presence, with headache being the most common side effect at 0.5%.
Floretyrosine F18 FDA approval
- ▪The FDA approval of floretyrosine F18 applies to adult and pediatric patients aged 1 month or older, to be used in conjunction with other diagnostic evaluations.
- ▪The FDA approved floretyrosine F18, under the brand name Pixclara developed by Telix Pharmaceuticals, as an intravenous PET imaging agent to differentiate recurrent or progressive glioma from treatment-related changes.
- ▪Floretyrosine F18 is the first floretyrosine PET (FET-PET) agent approved in the United States for glioma imaging.
FET-PET diagnostic mechanism
- ▪The National Comprehensive Cancer Network central nervous system cancer guidelines state that FET-PET and other amino acid PET options enhance diagnostic performance when combined with MRI.
- ▪Floretyrosine F18 combines the amino acid derivative floretyrosine, which is taken up by overexpressed amino acid transporters in gliomas, with the radioisotope fluorine-18 for PET detection.
Clinical trial evidence
- ▪The FDA approval of floretyrosine F18 was based on two clinical studies involving a total of 381 patients aged 5 to 85 years.
- ▪In clinical studies, readers using floretyrosine F18 PET imaging agreed with expert panels that brain changes were due to disease 66% to 83% of the time, and due to treatment 48% to 64% of the time.
FDA resubmission after rejection
- ▪The FDA declined Telix Pharmaceuticals' original approval application for floretyrosine F18 in April 2025, citing a lack of substantial evidence of effectiveness.
- ▪Telix Pharmaceuticals resubmitted its New Drug Application for floretyrosine F18 to the FDA in March 2026 after working with the agency.
Safety profile adverse events
- ▪Side effects of floretyrosine F18 occurring in fewer patients than headache included nausea, fatigue, malaise, and injection-site reactions.
- ▪Adverse events from floretyrosine F18 were uncommon in clinical studies, with headache being the most common side effect, occurring in 0.5% of patients.
Story comments
Loading comments…