Melbourne (Australia) | 18 March 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 MEB[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 the Netherlands to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

Illuccix®, after radiolabelling with gallium-68, is indicated in the Netherlands 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/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].

Marnix Lam, MD, Professor of Nuclear Medicine at UMC Utrecht commented, “PSMA-PET has had a profound impact on prostate cancer imaging, providing greater precision and confidence in diagnosis, staging and management of disease, compared to conventional imaging. The approval of Telix’s PSMA-PET agent in the Netherlands means that more hospitals will be able to integrate this innovative technology into routine clinical practice for the benefit of patients.”

Raphaël Ortiz, Chief Executive Officer, Telix International, added, “The approval of Illuccix® in the Netherlands will ensure broader availability of a clinically validated PSMA-PET product, allowing healthcare providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces our ongoing commitment to advancing prostate cancer care and expanding patient access to innovative diagnostic technologies across Europe”.

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

Prostate Cancer in the Netherlands

Prostate cancer is the most common cancer for men in the Netherlands with over 11,900 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (10,090 new cases) or lung cancer (7,793 new cases). Prostate cancer is the third most common cause of cancer death in men in the Netherlands, with just over 3,200 men dying from their disease in 2022[7].

[1] Positron emission tomography.

[2] Medicines Evaluation Board.

[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.