Telix Pharma Submits NDA To FDA For TLX101-CDx PET Agent For Brain Cancer

(RTTNews) - Telix Pharmaceuticals Limited (TLX.AX) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for TLX101-CDx, (Pixclara, 18F-floretyrosine or 18F-FET), an investigational PET agent for the characterization of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

Pixclara has been granted Orphan Drug and Fast Track designation by the FDA, which facilitates expedited review and closer consultation with the agency during the review process.

FET PET (Pixclara) is already included in international clinical practice guidelines for the imaging of gliomas, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.