Full Press Release Details
Melbourne (Australia) | 25 February 2025
Telix today announces that its prostate cancer PET [1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by ALMPS [2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Luxembourg to offer PSMA-PET [3] imaging using a clinically validated gallium-based radiopharmaceutical.
Illuccix, after radiolabelling with gallium-68, is indicated in Luxembourg for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings:
PSMA-PET imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT [4] scan) thereby offering a new standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP) [5] . Illuccix® PSMA-PET will help fulfil a critical unmet need by facilitating access to timely and effective diagnosis and patient selection for treatment with PSMA-targeted therapy.
Illuccix’s broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial [6] . With its broad indication and ready-to-use formulation, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows.
Raphaël Ortiz, Chief Executive Officer, Telix International, commented, “The approval of Illuccix® in Luxembourg will ensure this clinically validated PSMA-PET product is more widely available, allowing healthcare providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces Telix’s ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe”.
Healthcare professionals in Luxembourg interested in ordering Illuccix® or learning more about availability can contact customerservice.emea@telixpharma.com
About Illuccix
Telix’s prostate imaging product, gallium-68 ( 68 Ga) gozetotide injection (also known as 68 Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA) [8] , by the Australian Therapeutic Goods Administration (TGA) [9] , by Health Canada [10] , by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) [11] , and in multiple European Economic Area (EEA) Member States [12] . Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM [13] .
[1] Positron emission tomography.
[2] Luxembourg Agency for Medicines and Health Products.
[3] Imaging of prostate-specific membrane antigen with positron emission tomography.
[4] Computed tomography.
[5] EAU Guidelines. Edn. presented at the EAU Annual Congress Paris 2024. ISBN 978-94-92671-23-3.: https://uroweb.org/guidelines/prostate-cancer ; Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. 2023: https://www.esmo.org/guidelines/guidelines-by-topic/esmo-clinical-practice-guidelines-genitourinary-cancers/clinical-practice-guidelines-prostate-cancer/eupdate-prostate-cancer-treatment-recommendations
[6] ClinicalTrials.gov ID: NCT03511664 . VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for PSMA-PET imaging.
[7] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.
[8] Telix ASX disclosure 20 December 2021.
[9] Telix ASX disclosure 2 November 2021.
[10] Telix ASX disclosure 14 October 2022.
[11] Telix ASX disclosure 13 February 2025.
[12] Denmark, Luxembourg, Malta and Norway at time of release.
[13] Telix ASX disclosure 17 January 2025.