Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX) has achieved a major milestone with the European approval of Illuccix®, its prostate cancer PET imaging agent.
This approval, obtained through a Decentralized Procedure (DCP) led by Germany’s BfArM, marks a significant advancement in the availability of cutting-edge imaging technology across the European Economic Area (EEA). Illuccix® now transitions to the national implementation phase for individual market authorizations, paving the way for commercial launches in 19 European countries.
A New Standard in Prostate Cancer Imaging
Illuccix®, a kit for preparing gallium-68 (68Ga) gozetotide injections, is a groundbreaking tool for prostate cancer management. Recommended by leading organisations such as the European Association of Urology (EAU) and the European Society for Medical Oncology (ESMO), it is transforming diagnostic accuracy for:
- Primary disease staging: Offering superior accuracy over conventional imaging methods like CT scans and bone scans.
- Biochemical recurrence evaluation: Identifying disease persistence or recurrence earlier in the treatment pathway.
Kevin Richardson, CEO of Telix Precision Medicine, emphasized the clinical importance of Illuccix®:
“This positive decision enables us to bring a highly accurate imaging modality to patients and clinicians across Europe, aligning with global clinical guidelines for prostate cancer management.”
Global Impact of Illuccix®
Illuccix® is already a key diagnostic tool in Australia, Canada, and the United States, where it is approved for the preparation of 68Ga PSMA-11 injections. Its approval in Europe further extends its reach, enhancing the care pathway for prostate cancer patients worldwide.
About Illuccix®
Illuccix® enables the preparation of gallium-68 PSMA-11, a positron emission tomography (PET) imaging agent that binds to PSMA, a protein highly expressed in prostate cancer cells. This innovative imaging agent provides clinicians with detailed and precise insights into cancer staging and recurrence, enabling more effective treatment planning.
Telix’s European launch of Illuccix® is set to revolutionise prostate cancer imaging, offering patients a new standard of care across the region.
