Telix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted its new drug application (NDA) for Pixclara (TLX101-CDx) as a glioma-imaging agent, granting it priority review. This decision accelerates the review process, with a Prescription Drug User Fee Act (PDUFA) goal date set for April 26, 2025. The potential approval of Pixclara could significantly improve the accuracy of brain cancer imaging, addressing a critical unmet need in differentiating between tumor progression and treatment-related changes.
Addressing a Critical Need in Glioma Diagnosis
Gliomas, which constitute approximately 30% of all brain tumors, present significant diagnostic challenges. Current standard of care, MRI, often struggles to distinguish between true tumor progression and pseudo-progression, a treatment-induced change. Pixclara, a positron emission tomography (PET) agent, is designed to improve this differentiation in both adult and pediatric patients with progressive or recurrent glioma.
Kevin Richardson, chief executive officer of Telix Precision Medicine, emphasized the importance of this advancement, stating, "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. There is currently a critical need for better imaging in brain cancer."
Mechanism of Action and Clinical Development
Pixclara targets the membrane transport proteins LAT1 and LAT2, which are highly expressed in solid tumors, including central nervous system malignancies. This targeted approach allows for enhanced visualization of glioma cells. The agent may also serve as a companion diagnostic for Telix’s investigational glioblastoma therapy, TLX101 (131I-iodofalan, or 131I-IPA), which is currently under evaluation in the IPAX-201 and IPAX-Linz11 clinical trials.
Collaboration with UCSF
Telix has an exclusive research collaboration and data license agreement with the University of California, San Francisco (UCSF), which is conducting clinical research into the use of Pixclara in various neurological malignancies. Dr. Thomas A. Hope, professor of radiology at UCSF, highlighted the potential impact of Pixclara: "There is critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting, and we are excited to leverage the clinical experience at UCSF to help make this investigational agent more widely available. [Pixclara] has the potential to help determine if a glioma is truly progressing or undergoing a treatment-induced change, known as pseudo-progression, where MRI — the standard of care — can often be inconclusive."
Regulatory Designations
Pixclara has already received orphan drug designation and fast track designation from the FDA, underscoring its potential to address an unmet medical need in a rare disease. These designations provide incentives for development and expedite the review process.
