Telix Pharmaceuticals submits new drug application to US FDA for prostate cancer imaging product

Telix Pharmaceuticals

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).

Read Telix Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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US , Dossier , Diagnostic agent