Posted by Michael Wonder on 24 Sep 2020
Telix Pharmaceuticals submits new drug application to US FDA for prostate cancer imaging product
24 September 2020 - Telix Pharmaceuticals today announces it has submitted a new drug application to the United States FDA for TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for the imaging of prostate cancer using positron emission tomography.
Telix’s submission for TLX591-CDx includes clinical data from over 600 patients obtained from both prospective and retrospective clinical studies performed by Telix or in collaboration.
The submission also builds on definitive peer-reviewed clinical research conducted at leading academic centres including the University of California, Los Angeles (USA), the Peter MacCallum Cancer Centre (Australia) and Heidelberg University Hospital (Germany).
