Illuccix Prostate Cancer PSMA-PET Imaging Agent Approved in Greece

MELBOURNE, Australia, June 13, 2025 /PRNewswire/ --Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") 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 the Greek EOF^[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 Greece for PSMA-PET^[3] imaging using a clinically-validated, gallium-based radiopharmaceutical. 

Illuccix, after radiolabelling with gallium-68, is indicated in Greece 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^[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.

Access to PSMA-PET imaging in Greece remains extremely limited. During 2024, tracer and staff shortages meant that only 1,600 PSMA-PET examinations were conducted nationally, representing a small fraction of the 7,000 patients newly diagnosed each year. Illuccix's broad approval, supported by robust clinical data including the largest Ga-68-based PSMA data set from the VISION trial^[6], will help address these challenges.