FDA Accepts NDA for TLX101-Px Imaging Agent in Glioma

The U.S. Food and Drug Administration (FDA) has accepted a new drug application for TLX101-Px, an investigational PET imaging agent designed to help distinguish tumor progression from treatment-related changes in patients with glioma, according to a press release from Telix Pharmaceuticals Limited.

The application has been assigned a Prescription Drug User Fee Act goal date of Sept. 11, 2026.

TLX101-Px (Pixclara, Floretyrosine F 18) is being developed for imaging recurrent or progressive glioma in both adult and pediatric patients. If approved, the agent could address a longstanding challenge in neuro-oncology: accurately differentiating true tumor growth from post-treatment effects such as inflammation or radiation-related changes.

“There remains a critical unmet need in improving our ability to image residual glioma after treatment,” said Dr. Thomas Hope, vice chair of the Department of Radiology and Biomedical Imaging at the University of California, San Francisco, in the release. “We have worked with Telix for the last three years to help leverage our clinical data to help make FET-PET available to patients in the United States.”

For oncology nurses, improved imaging tools may help clarify disease status during follow-up, which can influence symptom assessment, patient education and coordination of care. Differentiating progression from treatment effects is especially important when patients report new or worsening neurologic symptoms, as imaging results often guide next steps in treatment planning.

Dr. Patrick Wen, of Mass General Brigham Cancer Institute, emphasized the clinical challenge this agent aims to address.

“Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care,” he said in the release. “PET imaging with 18F-FET is an important tool in clinical practice worldwide, and the FDA’s acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States.”

The imaging agent has already been recommended in international clinical practice guidelines, including those from the National Comprehensive Cancer Network, and has received both Fast Track and Orphan Drug designations from the FDA.

TLX101-Px works by targeting L-type amino acid transporters (LAT1 and LAT2), which are commonly overexpressed in glioma cells. This mechanism allows for more precise visualization of tumor activity compared with conventional imaging. The agent may also play a role in selecting patients and assessing response for a related investigational therapy, TLX101-Tx, currently being studied in recurrent glioblastoma.

Gliomas are the most common type of primary brain tumor, accounting for approximately 30% of all central nervous system tumors and 80% of malignant brain tumors. Glioblastoma, the most aggressive form, is associated with frequent recurrence despite standard treatment with surgery, radiation and chemotherapy.

For nurses, the potential availability of more accurate imaging may support clearer communication with patients about their disease status, particularly in cases where conventional scans are inconclusive. It may also help reduce uncertainty during surveillance and guide timely referrals or treatment adjustments.

Kevin Richardson, CEO of Telix Precision Medicine, described the FDA’s acceptance as a key milestone.

“The FDA’s acceptance of our NDA resubmission is an important milestone for Telix,” he said in the release. “We appreciate the FDA’s constructive engagement and look forward to working closely with the Agency to urgently obtain approval and then bring this product to market for the benefit of patients.”

TLX101-Px has not yet been approved in any country.

Reference

Telix Pharmaceuticals Limited. FDA accepts NDA for TLX101-Px (Pixclara®). GlobeNewswire. April 10, 2026.