Melbourne (Australia) | 15 April 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 the Swedish MPA[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 Sweden to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

Illuccix, after radiolabelling with gallium-68, is indicated in Sweden 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].

Rimma Axelsson, MD, Professor of Nuclear Medicine at Karolinska Institutet, commented on the approval “We are seeing an increasing demand for PSMA-PET imaging in Sweden, reflecting a shift in how prostate cancer is managed and inclusion in national guidelines. The benefits of accurate, timely imaging are well recognized, and a flexible gallium-based tracer like Illuccix will support many centers in meeting this need. This includes where infrastructure is limited or access to a cyclotron is not available, for example with smaller PET clinics and in regional locations.”

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, “This approval in Sweden follows recent authorizations in Norway and Denmark and reflects our commitment to expanding access to advanced imaging across the Nordic region. We’re pleased to be working with Wiik Pharma to provide healthcare professionals with clinically proven tools that support earlier diagnosis and more precise treatment decisions, where and when they’re needed most.”

Illuccix® will be made available in Sweden through Telix’s distribution partner for the Nordic region, Wiik Pharma ApS (Wiik Pharma), a specialist supplier and distributor of nuclear medicine products and services. To order or enquire about Illuccix® availability, authorized healthcare professionals in Sweden can email: info@wiikpharma.dk or call +45 5389 9010.

Prostate Cancer in Sweden

Prostate cancer is the most common cancer in Sweden overall and the most common cancer for Swedish men with over 11,700 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (4,037 new cases) or melanoma (2,697 new cases). Prostate cancer is also the most common cause of cancer death in men in Sweden, with over 2,400 men dying from their disease in 2022[7].

[1] Positron emission tomography.

[2] Medical Products Agency (Läkemedelsverket).

[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.