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FDA Approves New Brain Cancer Imaging Agent From Telix
The imaging drug is indicated for adults and children as young as one month old, and the company says it may improve treatment planning.
The United States Food and Drug Administration approved the New Drug Application for Pixclara, an amino acid positron emission tomography drug for imaging gliomas in adults and children.
Despite international guidelines recommending FET-PET imaging, no FDA-approved product was previously available in the United States, leaving a significant diagnostic gap for brain cancer patients.
Indicated for adults and children as young as one month old, Pixclara provides physicians with greater diagnostic certainty and confidence in treatment planning for glioma patients.
Outperforming the ASX Index, which declined 1%, Telix shares have risen as the company leverages its global diagnostics platform to target market leadership in precision medicine.
Pixclara is already the subject of a Phase 3 trial for diagnosis in additional brain conditions, with potential expansion to brain metastases in Telix's broader precision medicine pipeline.