FDA accepts Telix’s resubmitted NDA for TLX101-Px (Pixclara), an investigational 18F-FET PET imaging agent for glioma, with a PDUFA decision date set for September 11, 2026.
Written By: Pharmacally Medical News Desk
Telix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for TLX101-Px (Pixclara®, floretyrosine F-18 or 18F-FET), an investigational PET imaging agent for glioma. The agency assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 11, 2026.
If approved, TLX101-Px is intended to help characterize recurrent or progressive glioma and distinguish tumor progression from treatment-related changes in both adult and pediatric patients. The imaging agent has received both Orphan Drug and Fast Track designations from the FDA. Neuroimaging with 18F-FET is already recommended in international clinical practice guidelines, including NCCN Guidelines.
Clinical experts emphasized the diagnostic challenge in post-treatment glioma evaluation. Investigators involved in the development noted that accurately identifying residual or recurrent disease remains difficult, and FET-PET imaging could improve assessment of treated glioma. They added that FDA acceptance of the application represents progress toward broader availability of this imaging approach in the United States.
Telix leadership described the NDA acceptance as an important regulatory milestone and said the company plans to work closely with the FDA to advance review and potentially bring the product to market. The company also noted that no revenue from Pixclara is included in its fiscal year 2026 guidance.
TLX101-Px targets L-type amino acid transporters LAT1 and LAT2, membrane transport proteins commonly expressed in glioma. The imaging candidate may also support patient selection and response assessment for Telix’s LAT1-targeting therapeutic candidate TLX101-Tx (iodofalan I-131), which is currently being investigated in the pivotal IPAX-BrIGHT trial in patients with recurrent glioblastoma. Neither TLX101-Px nor TLX101-Tx has received marketing authorization in any jurisdiction.
Gliomas are diffusely infiltrative tumors arising from glial cells and represent the most common primary cancers of the central nervous system. They account for about 30% of all brain and CNS tumors and roughly 80% of malignant brain tumors.
Approximately 24,000 new glioma cases are diagnosed annually in the United States. Glioblastoma is the most aggressive form, and despite surgery followed by radiotherapy and chemotherapy, recurrence occurs in nearly all patients, with typical survival of 12 to 15 months from diagnosis.
Reference
FDA Accepts NDA for TLX101-Px (Pixclara®), 10 April 2026, https://telixpharma.com/news-views/fda-accepts-nda-for-tlx101-px-pixclara/