FDA approves Telix Pixclara as first FET-PET imaging drug for glioma
The FDA has approved Telix's Pixclara as the first FET-PET imaging agent in the United States for evaluating glioma, providing a new tool to help distinguish tumour progression from treatment-related changes.
Pixclara, or floretyrosine F 18, is a radioactive diagnostic imaging agent used with positron emission tomography to evaluate adults and paediatric patients with glioma.
The approval addresses a significant diagnostic challenge in brain cancer care by providing amino-acid PET imaging that can help clinicians assess suspected recurrent or progressive disease when conventional imaging may be inconclusive.
Field | Content |
Alert Type | Approval |
Drug Name | Floretyrosine F 18 |
Brand Name | Pixclara |
Company | Telix Pharmaceuticals |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | New diagnostic imaging drug approval |
Indication | PET imaging of adults and paediatric patients with glioma |
Therapy Area(s) | Oncology; neuro-oncology; diagnostic imaging |
Technology or Modality | FET-PET; radioactive diagnostic imaging agent |
Geography | United States |
What Happened | The FDA approved Pixclara (floretyrosine F 18), Telix's FET-PET imaging agent for use in adults and paediatric patients with glioma. |
Why It Matters | Pixclara is the first FDA-approved FET-PET imaging agent for glioma and provides clinicians with an additional tool for evaluating suspected recurrent or progressive brain cancer and distinguishing disease from treatment-related changes. |
Supporting Context | Conventional MRI can have difficulty distinguishing recurrent tumour from treatment effects, creating a need for more specific molecular imaging approaches in glioma management. |
Key Takeaway | Pixclara brings FDA-approved FET-PET imaging to the US for the first time, expanding diagnostic options for patients with glioma. |
What to Watch | US commercial rollout, availability across PET imaging centres and integration of FET-PET into glioma diagnosis and follow-up pathways. |
Primary Source | Telix Pharmaceuticals |
Relevant Date | 14 September 2026 |
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