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

Melbourne (Australia) | 29 August 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 Spain by AEMPS[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. Illuccix® is now approved in all 19 countries included in Telix’s decentralized procedure (DCP) submitted in Europe.

Illuccix, after radiolabelling with gallium-68, is indicated in Spain 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[3] 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[4]. 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.

The approval of Illuccix® is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial[5]. Despite the proven benefits of PSMA-PET imaging, access in Spain has been limited due to the relatively low number of clinical sites with gallium generators, particularly in regional locations. With Illuccix®, Telix will work directly with hospitals and other key stakeholders in Spain to ensure more equitable access to advanced prostate imaging throughout the country.

Dr. Marc Simó-Perdigó, Nuclear Medicine Specialist at Hospital Quirónsalud, Barcelona, commented, “PSMA-PET imaging has changed how we detect and monitor prostate cancer, offering greater accuracy and confidence in treatment planning. However, access remains limited in certain parts of Spain. The approval of Illuccix will help to resolve access challenges by enabling hospitals and clinics to prepare PSMA-PET locally, delivering more immediate patient access to this proven diagnostic tool.”

With its broad indication, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows.

“We are pleased that Illuccix has been approved in Spain, completing the national marketing authorization phase of Telix’s European submission. In Spain and across Europe, physicians will now have access to Telix’s gallium-based PSMA-PET imaging agent, with proven clinical benefit throughout the spectrum of prostate cancer care. This milestone reflects Telix’s commitment to enhancing access to state-of-the-art prostate cancer imaging solutions and the flexibility of generator-produced gallium,” said Raphaël Ortiz, Chief Executive Officer, Telix International.

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

Prostate Cancer in Spain

Prostate cancer is the most common cancer in men in Spain, with close to 33,000 new cases diagnosed annually, and a significantly higher incidence in men than either lung cancer (21,700 new cases) or bowel cancer (23,900 new cases). Prostate cancer was the third most common cause of cancer death in men, with over 6,000 men dying from their disease in Spain in 2022[6].

[1] Positron emission tomography.

[2] The Spanish Agency of Medicines and Medical Devices.

[3] Computed tomography.

[4] 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

[5] ClinicalTrials.gov ID: NCT03511664. VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for PSMA-PET imaging.

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