The FDA has accepted Telix Pharmaceuticals' New Drug Application (NDA) for TLX101-CDx (Pixclara), a PET imaging agent designed to improve the characterization of progressive or recurrent glioma in both adult and pediatric patients. The FDA granted priority review to Pixclara, setting a PDUFA goal date of April 26, 2025, potentially paving the way for commercial availability in the U.S. next year.
Pixclara (18F-floretyrosine or 18F-FET) is designed to address a critical unmet need in glioma management. Gliomas, the most common primary brain tumors, pose significant diagnostic challenges, particularly after treatment. Conventional MRI techniques often struggle to differentiate between tumor progression and treatment-related changes, leading to inconclusive results and delayed treatment decisions. Pixclara aims to provide greater clarity, potentially enabling more informed and timely treatment strategies.
"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."
Addressing Unmet Needs in Glioma Imaging
The limitations of conventional MRI in distinguishing tumor recurrence from treatment effects can significantly impact patient management. Pixclara, by targeting amino acid transport in tumor cells, offers a more biologically specific imaging approach. This specificity is crucial for accurate diagnosis and treatment planning, especially given the low survival rates associated with gliomas and the need for rapid clinical decision-making.
Potential as a Companion Diagnostic
Telix is also investigating the potential of Pixclara as a companion diagnostic for TLX101-Tx, an investigational neuro-oncology drug. Both agents target the same amino acid transporter mechanism, suggesting a synergistic approach to both diagnosing and treating gliomas. This dual application could further enhance precision medicine strategies in neuro-oncology.
Regulatory Designations
Pixclara has already received orphan drug and fast track designations from the FDA, underscoring its potential to address a significant unmet medical need in brain cancer imaging. If approved, Pixclara would be the first FDA-approved targeted amino acid PET agent commercially available in the U.S. for adult and pediatric brain cancer imaging. FET PET imaging is already included in international clinical practice guidelines for imaging gliomas.
