Telix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for TLX101-CDx (Pixclara®), a PET imaging agent designed for use in patients with glioma. The FDA has granted the application priority review, setting a Prescription Drug User Fee Act (PDUFA) goal date of April 26, 2025, which could lead to a U.S. commercial launch next year. This decision highlights the potential of Pixclara to address a critical unmet need in brain cancer diagnosis and management.
Addressing Unmet Needs in Glioma Imaging
Gliomas, the most common primary brain tumors of the central nervous system, present significant diagnostic challenges, especially in the post-treatment setting. Conventional MRI techniques often struggle to differentiate between tumor progression and treatment-related changes, leading to inconclusive results and delayed treatment decisions. Pixclara (18F-floretyrosine), aims to overcome these limitations by providing a more biologically specific assessment of tumor activity. Currently, while FET PET imaging is included in international clinical practice guidelines for gliomas, there is no FDA-approved targeted amino acid PET agent commercially available in the U.S. for this purpose. The FDA has previously granted Pixclara both orphan drug and fast track designations, underscoring its potential to fill this gap.
Mechanism and Clinical Significance
Pixclara utilizes 18F-floretyrosine to visualize the increased amino acid transport activity characteristic of glioma cells. This allows for improved characterization of progressive or recurrent tumors, distinguishing them from treatment-related changes. With low survival rates associated with gliomas and the need for rapid treatment decisions, precision imaging is crucial. Subject to regulatory approval, Pixclara promises to give clinicians greater clarity in diagnosis and treatment planning.
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. TLX101-Tx targets the same amino acid transporter mechanism as Pixclara but delivers therapeutic targeted radiation. This dual approach could further enhance the precision and effectiveness of brain cancer treatment.
Telix's Perspective
Kevin Richardson, Chief Executive Officer of 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. 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.”
