Pixclara approved as first FET-PET imaging agent for glioma
- Sponsor
- Telix Pharmaceuticals Limited $TLX
- Drug
- Pixclara · floretyrosine F 18
- Indication
- PET imaging to differentiate recurrent or progressive glioma from treatment-related change
FDA approved Telix's Pixclara (floretyrosine F 18), the first FDA-approved FET-PET imaging agent for glioma, for adults and children 1 month and older.
What this means
Glioma is the most common primary brain cancer, and after treatment doctors often cannot tell on a standard MRI whether new abnormalities are the tumor coming back or scarring and inflammation from radiation. Pixclara is an injected radioactive tracer used with a PET scan; it accumulates in actively growing tumor cells much more than in normal or treatment-damaged tissue, so the scan lights up recurrence clearly. FDA approved it Sept 14 for use in adults and children 1 month and older. This is the first FET-PET imaging agent approved in the US; the technique has been recommended in international guidelines and used in Europe for years, and Pixclara closes that US gap.