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.
