Melbourne (Australia) | 25 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 granted marketing authorization by MMA[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 Malta to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

Illuccix, after radiolabelling with gallium-68, is indicated in Malta 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, providing clinicians with more information than conventional imaging methods (bone scan, CT[4] scan) thereby offering a new 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, “We are delighted that Illuccix® has been approved in Malta with a broad label that demonstrates its clinical value at various key stages of the prostate cancer journey. This milestone highlights Telix’s continued commitment to improved patient outcomes throughout Europe, and means that doctors in Malta can benefit from the efficiencies and scheduling flexibility offered by generator-produced gallium”.

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

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 United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[11], and in multiple European Economic Area (EEA) Member States[12]. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM[13]. 

[1] Positron emission tomography.

[2] Malta Medicines Authority.

[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 13 February 2025.

[12] Denmark, Luxembourg, Malta and Norway at time of release.

[13] Telix ASX disclosure 17 January 2025.