Telix Pharmaceuticals has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its PET radiotracer TLX101-CDx (Pixclara) for imaging brain cancer.
The company is seeking approval for TLX101-CDx for the characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients. The imaging agent targets two membrane transport proteins known as large amino acid transporter 1, and large amino acid transporter 2 (LAT1 and LAT2), which are highly expressed in several types of cancer.
Earlier this year, the FDA granted TLX101-CDx fast-track designation, as well as opened an expanded access program for the imaging agent.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
