The FDA has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara), a PET imaging agent developed by Telix Pharmaceuticals for use in characterizing glioma. The FDA granted the application priority review, setting a PDUFA goal date of April 26, 2025, which could lead to a U.S. commercial launch next year.
Pixclara (18F-floretyrosine or 18F-FET) is designed to visualize progressive or recurrent glioma and differentiate between treatment-related changes in adult and pediatric patients. While FET PET imaging is already included in international clinical practice guidelines for gliomas, there is currently no FDA-approved targeted amino acid PET agent available in the U.S. for this purpose.
Unmet Need in Glioma Imaging
Gliomas, the most common primary brain tumors of the central nervous system, present a significant diagnostic challenge, particularly in the post-treatment setting. Conventional MRI techniques often struggle to differentiate between tumor progression and treatment-related effects due to limitations in biological specificity and reliance on blood-brain barrier disruption. This can lead to inconclusive results and delays in critical treatment decisions.
Pixclara's Potential Impact
Pixclara targets membrane transport proteins LAT1 and LAT2, potentially offering a more precise imaging approach. Subject to approval, Pixclara could provide clearer diagnoses and improve treatment decision-making for patients in the U.S. Telix is also exploring Pixclara as a companion diagnostic for TLX101-Tx, an investigational neuro-oncology drug that targets the same amino acid transporter mechanism with therapeutic targeted radiation.
Executive Perspective
"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," said Kevin Richardson, Chief Executive Officer, Telix Precision Medicine. "There is currently a critical need for better imaging in brain cancer, and Telix is dedicated to delivering precision medicine solutions that address patient needs and enhance both cancer imaging and treatment outcomes."
Glioma Statistics
Gliomas account for approximately 30% of all brain and CNS tumors and 80% of malignant brain tumors. In the U.S., there are approximately six new cases of gliomas diagnosed per 100,000 people annually. Glioblastoma (GBM), a high-grade glioma, accounts for approximately 22,000 new cases each year in the U.S. Despite aggressive treatment approaches, including surgical resection, radiotherapy, and chemotherapy, recurrence is common, and the expected survival duration is 12-15 months from diagnosis.
