Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in Belgium

Melbourne (Australia) | 23 June 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 AFMPS[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 Belgium to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

Illuccix, after radiolabelling with gallium-68, is indicated in Belgium for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings:

  • Primary staging of patients with high-risk PCa prior to primary curative therapy.
  • Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy.
  • Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.

PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT[4] scan) as the 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[5]. Illuccix PSMA-PET will help address an unmet clinical 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].

Patrick Flamen, MD, Professor of Nuclear Medicine at Institut Jules Bordet – Hôpital Erasme, commented, “With the approval of Illuccix in Belgium, we are entering a new era in the management of prostate cancer. This innovative PSMA-PET agent offers a precise diagnostic tool, enabling us to tailor treatments more effectively for our patients. Apart from its confirmed role as the most sensitive imaging tool for detecting disease sites, it is also crucial for selecting patients for PSMA targeted radiopharmaceutical therapy (theranostics). It is a significant advancement that will enhance patient outcomes and improve quality of life for those affected by this disease.”

Raphaël Ortiz, CEO, Telix International, added, “Belgium has been a fundamental part of Telix’s history and success, particularly with respect to the Illuccix kit, which was developed here by the company ANMI, later acquired by Telix. It is therefore particularly satisfying to “complete the circle” and make this clinically validated PSMA-PET agent available to Belgian physicians and their patients, so that they may 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”.

Pascale Delcomminette, CEO, Wallonia Export and Investment Agency (AWEX), continued, “The partnership forged with ANMI in 2017 marked the beginning of an incredibly successful journey for Telix Pharmaceuticals and its flagship imaging product, Illuccix. This collaboration has also benefited thousands of patients worldwide. ANMI, a spin-off from the University of Liège, was acquired and integrated into the Telix Group in late 2018, marking an important step for Telix’s establishment in Wallonia. Today, we are proud to count Telix Manufacturing Solutions (TMS) in Brussels South – Seneffe, which has recently completed the installation of two new cyclotrons and now received GMP accreditation. AWEX is excited and committed to supporting Telix as it embarks on its next phase of expansion in Belgium, confirming its leading European position in the radiopharmaceutical industry.”

Healthcare professionals in Belgium interested in ordering Illuccix or learning more about availability can contact customerservice.emea@telixpharma.com

Prostate Cancer in Belgium

Prostate cancer is the most common cancer for men in Belgium with more than 10,500 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (4,311 new cases) or lung cancer (5,469 new cases). Prostate cancer is the second most common cause of cancer death in men in Belgium, with over 1,900 men dying from their disease in 2022[7].

[1] Positron emission tomography.

[2] Agence fédérale des médicaments et des produits de santé (Federal 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.