Radiopharmaceutical company Telix Pharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for TLX591-CDx, its gallium-68-based radiopharmaceutical for PET imaging of prostate cancer.
Telix said that its NDA submission included clinical data from over 600 patients in both retrospective and prospective studies. TLX591-CDx targets the prostate-specific membrane antigen (PSMA) and was originally developed by the Heidelberg group of the German Cancer Research Center.
The vendor said it completed its European submission for the radiopharmaceutical earlier this year.
![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)
