FDA Accepts NDA for PET Imaging Agent for Glioma
KEY TAKEAWAYS
- The FDA accepted the NDA for Pixclara, an investigational PET imaging agent for glioma.
- The agent is designed to help differentiate tumor progression from treatment-related changes, a key challenge in glioma management.
- The FDA set a PDUFA date of September 11, 2026.
The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for Pixclara (TLX101-Px, floretyrosine F 18 or ¹⁸F-FET; Telix Pharmaceuticals), an investigational PET imaging agent for glioma. The agency assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 11, 2026.
Pixclara is intended to assist in the characterization of recurrent or progressive glioma and to help distinguish tumor progression from treatment-related changes—an area of ongoing clinical uncertainty in neuro-oncology. The agent targets L-type amino acid transporters (LAT1 and LAT2), which are upregulated in glioma cells, enabling visualization of metabolically active tumor tissue.
Differentiating true tumor progression from posttreatment effects such as radiation necrosis remains a major challenge in clinical practice, particularly in patients with high-grade gliomas. Amino acid PET imaging using ¹⁸F-FET is already incorporated into international clinical practice guidelines, although it is not currently widely available in the United States.
The FDA previously granted Pixclara Orphan Drug and Fast Track designations. According to the company, approval could address an unmet need for improved imaging tools in both adult and pediatric patients with suspected recurrent or progressive glioma. Telix Pharmaceuticals stated that Pixclara may also have applications beyond diagnosis, such as patient selection and response assessment for investigational therapies targeting LAT1. The company is currently evaluating a related therapeutic candidate, TLX101-Tx, in a pivotal trial in patients with recurrent glioblastoma.
Gliomas are the most common primary brain tumors, with approximately 24,000 new cases diagnosed annually in the United States. Despite multimodal treatment, recurrence is common, and prognosis remains poor for high-grade disease.
Source
Telix Pharmaceuticals Limited. FDA accepts NDA for TLX101-Px (Pixclara). PRNewswire. Published 10 April, 2026. Accessed 12 April, 2026. https://www.prnewswire.com/apac/news-releases/fda-accepts-nda-for-tlx101-px-pixclara-302738824.html