Illuccix Prostate Cancer PSMA-PET Imaging Agent Approved in Finland

Melbourne (Australia) | 30 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 Fimea[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 Finland to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

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

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, “Telix is committed to supporting people living with prostate cancer by working to improve access to accurate and reliable diagnostic imaging. The approval of Illuccix in Finland reflects the increasing importance of PSMA-PET in clinical decision-making. In partnership with our distributor, WIIk Pharma, we are focused on ensuring that healthcare providers across Finland can access a clinically validated imaging solution that is both effective and practical to implement. This milestone reinforces our ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe”.

Illuccix® will be made available in Finland 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 Finland can email: info@wiikpharma.dk or call +45 5389 9010.

Prostate Cancer in Finland

Prostate cancer is the most common cancer for men in Finland with over 5,900 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (2,123 new cases) or lung cancer (1,828 new cases). Prostate cancer is the second most common cause of cancer death in men in Finland, with just over 930 men dying from their disease in 2022[7].

About Illuccix®

Telix’s prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga 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 Brazilian Health Regulatory Agency (ANVISA)[11], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[12], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[13], and in multiple other European Economic Area (EEA) Member States[14]. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM[15].

[1] Positron emission tomography.

[2] The Finnish Medicines Agency.

[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 18 March 2025.

[12] Telix ASX disclosure 13 February 2025.

[13] National Agency for the Safety of Medicine and Health Products (Agence nationale de sécurité du médicament et des produits de santé). Telix media release 29 April 2025.

[14] Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release.

[15] The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025.