Full Press Release Details
Melbourne (Australia) | 23 July 2024
Telix today announces 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 ( 68 Ga) based agents. Its innovative properties are designed to facilitate more flexible production, including with higher activity 68 Ga sourced from both newer high activity generators and cyclotrons powered by the ARTMS® QUANTM 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 68 Ga 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 .
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®, and 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.”
TLX007-CDx has not received a marketing authorisation in any jurisdiction.
• Imaging of prostate-specific membrane antigen with positron emission tomography. ↩︎
• Prescription Drug User Fee Act. ↩︎
• Telix ASX disclosure 11 April 2024. For further information visit: https://www.artms.ca/ ↩︎
• FASTlab is a trademark of GE Healthcare and its affiliates. ↩︎
• NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024. ↩︎
• Company analysis based on proprietary and public domain data. ↩︎