Melbourne (Australia) | 11 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 approved by the Danish Medicines Agency (Lægemiddelstyrelsen).

Illuccix, after radiolabelling with gallium-68, is indicated in Denmark 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[2] represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT[3] 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)[4]. 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.

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, “We are delighted that Illuccix has been approved in Denmark with this broad label demonstrative of clinical utility at multiple critical points in the prostate cancer journey. Danish physicians and their patients will now have access to Telix’s innovative gallium-based PSMA-PET imaging agent, along with the efficiencies and scheduling flexibility of generator-produced gallium.”

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

Prostate Cancer in Denmark

Prostate cancer is the most common cancer among Danish men, with a high incidence rate (5,250 new cases in 2022[5]) and relatively poor survival compared to other Nordic countries[6].

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)[7], by the Australian Therapeutic Goods Administration (TGA)[8], and by Health Canada[9]. Illuccix is currently in national approval review in 19 European countries following a positive decentralized procedure (DCP) opinion by BfArM[10].

[1] Positron emission tomography.

[2] Imaging of prostate-specific membrane antigen with positron emission tomography.

[3] Computed tomography.

[4] 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

[5] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.

[6] Brasso et al. European Journal of Cancer. 2013.

[7] Telix ASX disclosure 20 December 2021.

[8] Telix ASX disclosure 2 November 2021.

[9] Telix ASX disclosure 14 October 2022.

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