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.
Dr. Theodore Pipikos, Head of Nuclear Medicine and PET/CT at Hygeia Hospital, Athens, welcomed the decision, commenting, "The approval of Illuccix marks a significant step forward in prostate cancer imaging for men in Greece. Given the structural barriers in our healthcare system, Illuccix provides healthcare practitioners with a widely accessible and much-needed tool to improve diagnostic accuracy."
Raphaël Ortiz, Chief Executive Officer, Telix International, added, "The approval of Illuccix in Greece will support more widely available PSMA-PET imaging, and enable more healthcare providers and their patients to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces Telix's ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic and therapeutic radiopharmaceuticals across Europe".
Illuccix will be made available in Greece through Telix's distribution partner BIOKOSMOS S.A. a key radiopharmaceutical manufacturer in Greece with a comprehensive distribution network, which covers the full Greek Territory as well as Cyprus.
Healthcare professionals in Greece interested in ordering Illuccix or learning more about availability can contact orders@biokosmos.gr or call +30 22920 63900.
Prostate Cancer in Greece
Prostate cancer is the most common cancer for men in Greece with over 7,000 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (4,346 new cases) or lung cancer (6,357 new cases). Prostate cancer is the third most common cause of cancer death in men in Greece, with just over 1,900 men dying from their disease in 2022[7].
About Illuccix
Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the United States Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the Brazilian Health Regulatory Agency (ANVISA)[11], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[12], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[13], by the German Federal Institute for Drugs and Medical Devices (BfArM), and in multiple countries within the European Economic Area (EEA)[14] following a positive decentralized procedure (DCP) opinion by the German medical regulator[15].
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
Legal Notices
You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.
The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.
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©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates - all rights reserved. Trademark registration status may vary from country to country.
[1] Positron emission tomography. |
[2] ??F, ??????? ???a??sµ?? Fa?µ???? (National Organization for Medicines). |
[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. |
[8] Telix ASX disclosure 20 December 2021. |
[9] Telix ASX disclosure 2 November 2021. |
[10] Telix ASX disclosure 14 October 2022. |
[11] Telix ASX disclosure 18 March 2025. |
[12] Telix ASX disclosure 13 February 2025. |
[13] Telix media release 29 April 2025. |
[14] Czech Republic, Denmark, Finland, Greece, Ireland, Luxembourg, Malta, the Netherlands, Norway, Portugal and Sweden at time of release. |
[15] Telix ASX disclosure 17 January 2025. |
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