New approval provides hospitals and clinics in the Czech Republic with access to a proven PSMA-PET imaging agent
MELBOURNE, Australia, May 5, 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 in the Czech Republic by the SÚKL[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 provides healthcare providers in the Czech Republic with broader access to PSMA-PET[3] imaging, using a clinically validated gallium-based radiopharmaceutical.
Illuccix, after radiolabelling with gallium-68, is indicated in the Czech Republic 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 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].
President of the Czech Society of Nuclear Medicine, Dr. David Zogala commented on the approval, "Waiting for a diagnosis can be a difficult time for men with suspected prostate cancer. In this regard, PSMA-PET imaging has transformed how we assess the disease, offering greater accuracy and confidence in determining its stage, and guiding the correct course of action. The approval of Illuccix will increase access to advanced imaging in the Czech Republic, broadening the portfolio of available PSMA tracers and supporting precise detection and timely decision-making for patients."
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.
"The Czech Republic has been at the forefront of adopting advanced diagnostics, with Czech nuclear medicine specialists playing a leading role in integrating PSMA-PET imaging into clinical practice. We are pleased to support their efforts by working with THP Medical Products to deliver Illuccix, a clinically validated imaging solution that will help ensure more men benefit from accurate prostate cancer detection and ongoing management." said Raphaël Ortiz, Chief Executive Officer, Telix International.
Illuccix® will be made available in the Czech Republic through Telix's distribution partner THP Medical Products a specialist supplier and distributor of nuclear medicine products and services. To order or enquire about Illuccix® availability, authorized healthcare professionals in the Czech Republic can email: objednavky@thp-medical.cz or call +43 1 292 82 80.
Prostate Cancer in the Czech Republic
Prostate cancer is the most common cancer in men in the Czech Republic, with close to 8,000 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (4,376 new cases) or lung cancer (3,709 new cases). Prostate cancer is also the third most common cause of cancer death in men, with over 1,600 men dying from their disease in the Czech Republic 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 U.S. Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[11], by the Brazilian Health Regulatory Agency (ANVISA)[12], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[13], and in multiple other European Economic Area (EEA) Member States[14]. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM[15].
[1] Positron emission tomography. |
[2] Státní Ústav Pro Kontrolu Léciv (State Institute for Drug Control). |
[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] 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 13 February 2025. |
[12] Telix ASX disclosure 18 March 2025. |
[13] National Agency for the Safety of Medicine and Health Products (Agence nationale de sécurité du médicament et des produits de santé). Telix media release 29 April 2025. |
[14] Czech Republic, Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release. |
[15] The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025. |
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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. 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.
This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.
©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.
Logo - https://mma.prnewswire.com/media/1920208/Telix_Main_Logo_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/telixs-illuccix-psma-pet-imaging-agent-approved-in-the-czech-republic-302445852.html
