Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in Austria

Melbourne (Australia) | 18 July 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 BASG[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 Austria to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

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

Professor Dr. Michael Gabriel, Head of the Institute of Nuclear Medicine and Endocrinology at Kepler University Hospital in Linz, and President of the Austrian Society of Nuclear Medicine and Theranostics (OGNT) commented on the approval, “PSMA-PET imaging has changed the way we detect and monitor prostate cancer, giving us far greater accuracy than conventional methods. In Austria, where prostate cancer is the most common cancer in men, having access to reliable imaging tools is vital for making well-informed treatment decisions. I welcome the approval of Illuccix as a clinically validated option to support precise diagnosis and help ensure patients receive the most appropriate care.”

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, “The approval of Illuccix in Austria expands access to PSMA-PET imaging, supporting clinicians in delivering precision oncology for men with prostate cancer. We are committed to enabling better-informed treatment decisions through our innovative radiopharmaceutical portfolio and through our distributor THP Medical Products. We look forward to working with healthcare providers to ensure more patients can benefit from this advanced imaging solution.”

Illuccix will be made available in Austria through Telix’s distribution partner THP Medical Products a specialist supplier and distributor of nuclear medicine products and services. To order or enquire about Illuccix availability, authorized healthcare professionals in Austria can email:  orders.nuk@thp.at or call +43 1 292 82 80.

Prostate Cancer in Austria

Prostate cancer is the most common cancer for men in Austria with more than 5,900 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (2,616 new cases) or lung cancer (3,004 new cases). Prostate cancer is the second most common cause of cancer death in men in Austria, with over 1,300 men dying from their disease in 2022[7].

[1] Positron emission tomography.

[2] Bundesamt für Sicherheit im Gesundheitswesen (Austrian Medicines and Medical Devices 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.