The U.S. Food and Drug Administration (FDA) has accepted Telix Pharmaceuticals' New Drug Application (NDA) for TLX101-CDx (Pixclara), a PET imaging agent designed for the characterization of glioma. The FDA has granted the application priority review, setting a Prescription Drug User Fee Act (PDUFA) goal date of April 26, 2025.
Pixclara (18F-floretyrosine or 18F-FET) is designed to image progressive or recurrent glioma and to differentiate between tumor progression and treatment-related changes in both adult and pediatric patients. Currently, there is no FDA-approved targeted amino acid PET agent commercially available in the U.S. for brain cancer imaging, making Pixclara a potential solution for a significant unmet medical need.
Unmet Need in Glioma Imaging
Gliomas, the most common primary brain tumors of the central nervous system, present significant diagnostic challenges. Conventional MRI techniques often lack the biological specificity needed to distinguish between tumor progression and treatment-related effects, leading to inconclusive results and delayed treatment decisions. Approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors are gliomas. Glioblastoma (GBM), a high-grade glioma, accounts for approximately 22,000 new cases annually in the U.S. Despite aggressive treatment involving surgical resection, radiotherapy, and chemotherapy, recurrence is common, with a median survival of 12-15 months from diagnosis.
Pixclara's Potential Impact
Pixclara targets membrane transport proteins LAT1 and LAT2, which are overexpressed in glioma cells. This targeted approach allows for more precise imaging, potentially improving diagnostic accuracy and treatment planning. Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, stated, "Telix believes that the FDA approval of Pixclara will drive a step-change for brain cancer imaging in the U.S., and bring it into line with a more advanced standard of care currently used in other markets."
Companion Diagnostic Potential
Telix is also exploring Pixclara's potential as a companion diagnostic agent for TLX101-Tx, an investigational neuro-oncology drug that targets the same amino acid transporter mechanism with therapeutic targeted radiation. TLX101 (131I-iodofalan, or 131I-IPA) is currently under investigation in the IPAX-2 and IPAX-Linz studies.
Regulatory Designations
Pixclara has been granted both orphan drug and fast track designations by the FDA. Fast Track designation expedites the development and review of drugs that treat serious conditions and fill unmet medical needs. Orphan drug designation provides incentives to develop drugs for rare diseases.
