The U.S. Food and Drug Administration (FDA) has accepted Telix Pharmaceuticals Limited's New Drug Application (NDA) for TLX101-CDx (Pixclara), a positron emission tomography (PET) imaging agent designed for the characterization of glioma in both adult and pediatric patients. The FDA has granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 26, 2025, signaling a potential U.S. commercial launch in 2025. This decision aims to address the critical need for improved diagnostic tools for gliomas, which represent approximately 30% of all brain and central nervous system tumors and 80% of malignant brain tumors.
Addressing Unmet Needs in Glioma Imaging
Gliomas, known for their diffusely infiltrative nature, pose significant diagnostic challenges. Conventional magnetic resonance imaging (MRI) techniques often fall short due to limitations in biological specificity and the inability to differentiate between tumor progression and treatment-related changes. This can lead to inconclusive results and delays in crucial treatment decisions. Pixclara (18F-floretyrosine or 18F-FET) offers a targeted approach by imaging the LAT1 and LAT2 membrane transport proteins, which are highly expressed in gliomas.
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. 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."
Potential as a Companion Diagnostic
Pixclara has been granted both fast track and orphan drug designations by the FDA, underscoring its potential to address a significant unmet medical need. Telix is also exploring Pixclara's utility as a companion diagnostic agent for TLX101-Tx (131I-iodofalan, or 131I-IPA), an investigational neuro-oncology drug targeting the same amino acid transporter mechanism with therapeutic targeted radiation. TLX101 is currently under investigation in the IPAX-210 and IPAX-Linz studies.
Glioma Statistics and Current Treatment Landscape
In the U.S., approximately six cases of gliomas are diagnosed per 100,000 people annually. Glioblastoma (GBM), a high-grade glioma, accounts for approximately 22,000 new cases each year. The standard treatment for GBM involves surgical resection followed by combined radiotherapy and chemotherapy. Despite these interventions, recurrence is common, with an expected survival duration of 12-15 months from diagnosis. The limitations of current imaging modalities highlight the need for more precise diagnostic tools like Pixclara to improve patient outcomes.
