Clinical Report: FDA approves FET-PET agent for glioma

Overview

The FDA has approved floretyrosine F 18 (Pixclara) for PET imaging to differentiate recurrent glioma from treatment-related changes in patients aged 1 month or older. This marks the first FDA approval of an FET-PET imaging drug for glioma.

Background

Gliomas are the most common primary tumors of the central nervous system, with approximately 24,000 new cases diagnosed annually in the US. Accurate differentiation between recurrent glioma and treatment-related changes is critical. The approval of floretyrosine F 18 aligns with international guidelines recommending its use in glioma imaging.

Data Highlights

Floretyrosine F 18 was evaluated in 382 patients with gliomas, including 371 adults and 11 pediatric patients. The safety profile showed headache in 0.5% of patients, with nausea, injection-site reaction, fatigue, and malaise occurring in fewer than 0.5%.

Key Findings

• Floretyrosine F 18 is the first FDA-approved FET-PET imaging agent for glioma.
• Approximately 24,000 new glioma cases are diagnosed annually in the US.
• Image misinterpretation may occur, necessitating the incorporation of other diagnostic information.
• Floretyrosine F 18 adds to cumulative radiation exposure, which is associated with an increased risk of cancer.

Clinical Implications

The approval of floretyrosine F 18 provides clinicians with a new tool for distinguishing between recurrent glioma and treatment-related changes.

Conclusion

The FDA's approval of floretyrosine F 18 supports the use of FET-PET imaging in glioma.

Related Resources & Content

1. Telix Pharmaceuticals, Press Release, 2023 -- FDA approves floretyrosine F 18 (Pixclara) for glioma
2. Journal of Neuro-Oncology, 2022 -- Radiomic Analysis of Static FET PET Imaging for Distinguishing Treatment-Induced Changes from Glioma Advancement
3. Journal of Neuro-Oncology, 2021 -- Utilization of 18F-FET-PET for Enhanced Gross Total Resection and Improved Survival Outcomes in Patients with WHO Grade III/IV Gliomas
4. Journal of Neuro-Oncology, 2022 -- Utilization of [18F]fluorodopa PET Imaging for Glioma Grading
5. Update to the RANO working group and EANO recommendations for the clinical use of PET imaging in gliomas, 2025
6. the asco post — FDA Approves Piflufolastat F-18 Injection, a PSMA PET Imaging Agent, for the Detection of Metastatic or Recurrent Prostate Cancer
7. Diagnostic Value of PET Tracers in Differentiating Glioma Tumor Recurrence from Treatment-Related Changes: A Systematic Review and Meta-Analysis
8. PET-based response assessment criteria for diffuse gliomas (PET RANO 1.0): a report of the RANO group
9. Update to the RANO working group and EANO recommendations for the clinical use of PET imaging in gliomas