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July 24, 2024 — Telix Pharmaceuticals Limited announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit ("Kit") for the preparation of PSMA-PET imaging[1] for prostate cancer. The PDUFA[2] goal date is March 24, 2025.
If approved, the new Kit will enable use of a PSMA imaging product with a considerably extended geographic distribution radius from a nuclear pharmacy compared to currently approved gallium-68 (68Ga) based agents. Its innovative properties are designed to facilitate more flexible production, including with higher activity 68Ga sourced from both newer high activity generators and cyclotrons powered by the ARTMSQUANTM Irradiation System[3] and GE FASTlab [4] solid and liquid target production system. Through this NDA, Telix's objective is to further enhance patient access to PSMA-PET imaging and the clinical benefits of 68Ga imaging to underserved populations across the U.S., using Telix's established nuclear pharmacy distribution partnerships and industry-leading on-time reliability.
PSMA-PET imaging represents a major advancement in prostate cancer management and in the U.S. has replaced conventional imaging methods (bone scan, CT scan) as the standard of care after initial diagnosis and biochemical recurrence[5]. Despite this major medical advancement, only a relatively small fraction of the 3.4 million men living with prostate cancer in America have undergone a PSMA-PET imaging scan[6],[7].
Dr Christian Behrenbruch, Managing Director and Group CEO of Telix stated, "We have seen rapid adoption and geographic expansion of PSMA-PET imaging with our first commercial product Illuccix. This filing acceptance is an important step towards further improving equity of access and reinforcing our commitment to innovation in prostate cancer to continue to meet the needs of healthcare professionals and their patients. We now look forward to working with the FDA to bring TLX007-CDx to American men living with prostate cancer, including those residing in underserved communities and regions where access to state-of-the art imaging remains limited."
For more information: www.telixpharma.com
References:
[1] Imaging of prostate-specific membrane antigen with positron emission tomography.
[2] Prescription Drug User Fee Act.
[3] Telix ASX disclosure 11 April 2024. For further information visit: https://www.artms.ca/
[4] FASTlab is a trademark of GE Healthcare and its affiliates.
[5] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024.
[6] NIH Common Cancer Sites — Cancer Stat Facts. Accessed May 2024.
[7] Company analysis based on proprietary and public domain data.
[8] Telix ASX disclosure 20 December 2021.
[9] Telix ASX disclosure 2 November 2021.
[10] Telix ASX disclosure 14 October 2022.
November 14, 2025 
