Telix’s Illuccix® PSMA-PET Imaging Agent Approved in Italy

Melbourne (Australia) | 24 June 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 in Italy by the AIFA[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 across Italy to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

Illuccix, after radiolabelling with gallium-68, is indicated in Italy 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 advance in prostate cancer management, largely replacing conventional imaging methods such as bone scans and CT[4] scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognise its superior accuracy in staging primary disease and assessing BCR[5]. Illuccix PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy.

In Italy, an increase in demand for PSMA-PET imaging is being driven by a combination of growing clinical guideline recommendations and increased awareness of the technology’s benefits. However, despite the proven benefits, many patients continue to face long wait times due to tracer shortages and infrastructure constraints, particularly in regional locations. Illuccix has the potential to resolve access challenges by enabling hospitals and clinics to prepare PSMA-PET scans on-site, providing a faster, more accessible solution for physicians.

Professor Stefano Fanti, Director of Nuclear Medicine at the Policlinico S. Orsola and Director of Speciality School of Nuclear Medicine at the University of Bologna, Bologna, Italy, commented, “PSMA-PET imaging has significantly improved the detection and monitoring of prostate cancer, offering greater accuracy in treatment planning. The approval of Illuccix in Italy is timely, as more PET centers, particularly in regional and smaller hospitals, are adopting Ga-68, with a growing number also offering Lu-177 therapy. Illuccix will help address some of the access challenges that have previously delayed diagnosis, providing healthcare providers with a more readily available option for effective patient management.”

With its broad indication, Illuccix is designed to support healthcare providers in delivering efficient and reliable imaging, integrating with existing hospital workflows.

“We are pleased that Illuccix has been approved in Italy with this broad label that reflects clinical value at multiple stages of prostate cancer care. This approval will ensure that physicians now have access to Telix’s gallium-based PSMA-PET imaging agent, which offers high diagnostic accuracy alongside the efficiency and flexibility of generator-produced gallium. This milestone reflects our commitment to expanding access to world-class prostate cancer imaging solutions across Europe” said Raphaël Ortiz, Chief Executive Officer, Telix International.

Illuccix will be distributed in Italy by Radius S.r.l., the market leader in the supply of gallium generators across Italy, a position which enables Radius to provide a secure supply of the 68Ga necessary for launching Illuccix. Radius also has the advantage of being a supplier and service provider for cyclotrons and radiotherapy suites across Italy.

Healthcare professionals in Italy interested in ordering Illuccix or learning more about availability can contact commerciale@radiustech.it or call +39 051 801160.

Prostate Cancer in Italy

Prostate cancer is the most common cancer in men in Italy, with over 38,000 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (29,225 new cases) or lung cancer (28,450 new cases). Prostate cancer is also the third most common cause of cancer death in men, with over 8,100 men dying from their disease in Italy in 2022[6].

[1] Positron emission tomography.

[2] Agenzia Italiana del Farmaco (Italian Medicines Agency).

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

[4] Computed tomography.

[5] European Association of Urology (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: European Society for Medical Oncology (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] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.