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# Priority Review for Glioma Imaging Agent
- URL: https://www.fdaweb.com/priority-review-for-glioma-imaging-agent/
- Published: 2024-10-24T12:00:00.000Z
- Updated: 2026-09-14T14:44:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158055

FDA has accepted for priority review a Telix NDA for Pixclara (18F-floretyrosine), a positron emission tomography agent for glioma imaging. The agency has set a user fee review action target date of 4/26/2025\. The therapy is intended for use to provide a characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients.

The company says that if approved Pixclar would help address a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors. “Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes,” it says.