FDA Accepts Telix Pharmaceuticals' NDA for PET Imaging Agent TLX101-Px

The United States Food and Drug Administration (FDA) has accepted Telix Pharmaceuticals' New Drug Application (NDA) for TLX101-Px (Pixclara®, Floretyrosine F 18). This investigational PET imaging agent is designed for diagnosing gliomas, a prevalent type of brain cancer. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 11, 2026, for this application.

TLX101-Px aims to meet a critical need in differentiating between recurrent or progressive gliomas and treatment-induced changes in both adult and pediatric demographics. Glioma imaging utilizing Floretyrosine F 18 is already advocated by international clinical practice guidelines, including those of the National Comprehensive Cancer Network® (NCCN). In recognition of its potential, TLX101-Px has received both Orphan Drug and Fast Track designations from the FDA.

Doctors involved in neuro-oncology have voiced optimism regarding the application. Thomas Hope, MD, Vice Chair of the Department of Radiology and Biomedical Imaging at the University of California, San Francisco, emphasized the pressing need for enhanced imaging solutions post-treatment. "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," Hope stated.

Additionally, Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, remarked on the importance of the acceptance: “Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care. 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.”

Kevin Richardson, CEO of Telix Precision Medicine, noted the milestone's significance. "The FDA’s acceptance of our NDA resubmission is an important milestone for Telix. 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.”

Gliomas represent the most common primary brain and CNS tumors, accounting for 30% of all such tumors and 80% of malignant brain tumors. Annually, approximately 24,000 new glioma cases are reported in the U.S. The aggressive nature of glioblastomas, the most prevalent type of high-grade gliomas, highlights the urgent need for improved diagnostic tools like TLX101-Px to enhance patient outcomes through more accurate imaging.