FDA approves FET-PET agent for glioma - Summary - MDSpire
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FDA approves FET-PET agent for glioma

The radioactive diagnostic drug is indicated in patients aged 1 month or older and is used in conjunction with other diagnostic evaluations.

  • By

  • Kathryn Wighton

  • September 14, 2026

  • 2 min

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Objective:

To inform about the FDA approval of floretyrosine F 18 (Pixclara) for PET imaging in glioma.

Approach:
  • FDA Approval: The FDA approved floretyrosine F 18 for differentiating recurrent or progressive glioma from treatment-related changes.
  • Clinical Use: Floretyrosine F 18 is the first FDA-approved FET-PET imaging drug for glioma, recommended in international clinical practice guidelines.
  • Administration and Mechanism: Floretyrosine F 18 is administered intravenously and targets L-type amino acid transporters, incorporating fluorine-18 for PET detection.
  • Safety Evaluation: Safety was evaluated in 382 patients, with minimal adverse effects reported.
Key Findings:
  • Floretyrosine F 18 is approved for use in adults and pediatric patients aged 1 month or older.
  • Approximately 24,000 new glioma cases are diagnosed annually in the US.
Interpretation:

PET results should be interpreted with caution, as they cannot definitively exclude or establish recurrent glioma.

Limitations:
  • Image misinterpretation may occur, leading to false-positive or false-negative results.
Conclusion:

FDA approval of Pixclara will enhance access to FET-PET imaging in the US.

Sources:

Original Source(s)

FDA approves FET-PET agent for glioma

  • by Kathryn Wighton

  • September 14, 2026

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