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Telix Pharmaceuticals Submits New Drug Application to US FDA for Prostate Cancer Imaging Product GlobeNewswire September 23, 2020 MELBOURNE, Australia and INDIANAPOLIS, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announces it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (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 (PET).1 Telix’s NDA 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).
Source: AsiaOne