Telix Submits NDA to FDA for Pixclara, a Brain Cancer Imaging Agent
Key Insights
Telix Pharmaceuticals has submitted an NDA to the FDA for Pixclara (floretyrosine F-18 (search)), a PET imaging agent, to characterize progressive or recurrent glioma (search).
Pixclara has received Orphan Drug and Fast Track designations from the FDA, potentially expediting the review process and facilitating closer consultation with the agency.
If approved, Pixclara could address a critical unmet need in glioma (search) diagnosis, offering improved clarity in diagnosis and treatment decision-making for both adult and pediatric patients.
Telix Pharmaceuticals has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TLX101-CDx, known as Pixclara™ (floretyrosine F-18 (search)). This investigational PET imaging agent is intended for characterizing progressive or recurrent glioma (search) (brain cancer (search)) and differentiating it from treatment-related changes in both adult and pediatric patients.
Addressing Unmet Needs in Glioma Diagnosis
Pixclara has been granted Orphan Drug and Fast Track designations by the FDA, highlighting its potential to address significant unmet medical needs. These designations may expedite the review process and allow for closer consultation with the agency. Currently, while FET PET (Pixclara) is included in international clinical practice guidelines for glioma (search) imaging, there is no FDA-approved targeted amino acid PET agent commercially available in the U.S. for adult and pediatric brain cancer (search).
Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, stated, “Gliomas are the most common primary brain tumors of the central nervous system. Conventional imaging with MRI often yields inconclusive results in characterizing recurrent disease and therefore delays time-sensitive decision making. Telix’s filing of this NDA for Pixclara is an important milestone, reflecting our commitment to improved and accessible neuro-oncology imaging in the U.S., and taking us one step closer to commercial availability in 2025, subject to FDA approval.”
About TLX101-CDx (Pixclara)
TLX101-CDx (Pixclara) is a PET imaging agent targeting membrane transport proteins LAT1 and LAT2 (search). It has received fast track and orphan drug designations from the FDA for glioma (search) characterization. Telix is also developing Pixclara as a companion diagnostic agent for TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA), its LAT1-targeting investigational glioblastoma (search) (GBM) therapy, which is currently under investigation in the IPAX-2 and IPAX-Linz studies.
Glioma Statistics and Current Treatment Landscape
Gliomas are highly infiltrative tumors affecting surrounding brain tissue and represent approximately 30% of all brain and CNS tumors, and 80% of malignant brain tumors. In the U.S., there are approximately six cases of gliomas diagnosed per 100,000 people annually. Glioblastoma (search) (GBM) is a high-grade glioma (search) and the most common and aggressive form of primary brain cancer (search), with about 22,000 new cases diagnosed each year in the U.S. The standard treatment for GBM includes 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.