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# Telix NDA Resubmission for Brain Cancer Imaging Agent
- URL: https://www.fdaweb.com/telix-nda-resubmission-for-brain-cancer-imaging-agent/
- Published: 2026-04-10T12:00:00.000Z
- Updated: 2026-09-14T13:37:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160965

FDA has accepted a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma, and set a user fee review action date of 9/11\. A year ago, FDA issued Telix a complete response letter on its NDA , saying it could not be approved in its current form and that additional confirmatory clinical evidence is required, according to the company.

According to Telix, the candidate has received both Orphan Drug Designation and Fast Track Designation from the FDA because of its potential to address an unmet medical need. The company noted that although PET imaging with the tracer 18F-FET is already included in international clinical practice guidelines for glioma imaging, there is currently no FDA-approved targeted amino acid PET imaging agent for brain cancer available commercially in the U.S.

Pixclara targets amino acid transport proteins known as LAT1 and LAT2, which are commonly expressed in glioma cells, according to the company. The imaging agent may also serve as a potential companion diagnostic for Telix’s investigational therapeutic candidate TLX101-Tx, a LAT1-targeted radiopharmaceutical therapy currently being studied in the IPAX-BrIGHT trial for glioblastoma.

Gliomas are the most common tumors originating in the central nervous system and account for roughly 30% of all brain and central nervous system tumors and about 80% of malignant brain tumors, it says. The most aggressive subtype, glioblastoma, is diagnosed in about 22,000 patients in the U.S. each year.