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

Melbourne (Australia) | 4 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 Portugal by INFARMED[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 enhances the options available to healthcare providers across Portugal for PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

Illuccix, after radiolabelling with gallium-68, is indicated in Portugal 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 such as bone scans and CT[4] scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognize 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.

Illuccix’s broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial[6]. Despite the proven benefits of PSMA-PET imaging, patients in Portugal have faced long wait times due to tracer shortages and infrastructure constraints.

Dr. Fernando Abreu, Director of Nuclear Medicine at the Santa Maria Local Health Unit, commented, “PSMA-PET imaging has significantly enhanced the accuracy and confidence in the detection and monitoring of prostate cancer. However, Portugal is currently facing a shortage of gallium-68 tracers, which has resulted in a national waiting list of up to six months. This delay has an impact on the timely diagnoses and treatments impacting patient care. The approval of Illuccix® in Portugal will be welcomed by physicians and patients as it allows hospitals and clinics to conduct PSMA-PET scans more efficiently, and with shorter wait times.”

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.

Illuccix® will be distributed in Portugal by Sociedade Avanço, Unipessoal, LDA (Avanço), a specialist distributor of nuclear medicine, radiotherapy technologies and urology biopsy products.

“The approval of Illuccix® in Portugal marks an important milestone, providing healthcare professionals with access to a gallium-based PSMA-PET imaging agent supported by strong clinical validation. Our partnership with Avanço will help address the current shortages of gallium tracers and enable more efficient scanning processes. This collaboration reflects Telix’s ongoing commitment to expanding access to high-quality prostate cancer imaging across Europe and reducing the barriers that currently delay diagnosis and treatment.” said Raphaël Ortiz, Chief Executive Officer, Telix International.

Mr. Diogo Marcos, Managing Director of Avanço added: “We are delighted to partner with Telix for the distribution of Illuccix® in Portugal. As the official distributor of the GalliaPharm®[7] generator, currently the only generator with marketing approval in the country, we are uniquely positioned to help address the national shortage of gallium-68. Our established distribution network ensures nationwide access, and our collaboration with Telix will enable us to support physicians in delivering timely and accurate PSMA-PET imaging.“

Healthcare professionals in Portugal interested in ordering Illuccix® or learning more about availability can contact comercial@ams.pt or call (+351) 214 380 690.

Prostate Cancer in Portugal

Prostate cancer is the most common cancer in men in Portugal, with just over 7,500 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (6,092 new cases) or lung cancer (4,253 new cases). Prostate cancer is also the third most common cause of cancer death in men, with just over 2,080 men dying from their disease in Portugal in 2022[8].

[1] Positron emission tomography.

[2] National Authority of Medicines and Health Products, I.P.

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

[7] GalliaPharm® is a registered trademark of Eckert & Ziegler SE.

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