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# FDA Turns Down Telix Glioma Imaging Agent
- URL: https://www.fdaweb.com/fda-turns-down-telix-glioma-imaging-agent/
- Published: 2025-04-28T12:00:00.000Z
- Updated: 2026-09-14T15:10:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159073

FDA has issued Telix Pharmaceuticals a complete response letter on its NDA for Pixclara (floretyrosine F18), a positron emission tomography agent for imaging gliomas, a rare and life-threatening brain cancer. The letter says the NDA cannot be approved in its current form and that additional confirmatory clinical evidence is required, according to the company, adding that it will request a meeting with the agency to review the basis for the decision.

The NDA was accepted for priority review 10/2024\. The imaging agent is intended for use to provide a characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients, Telix says.

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.