MELBOURNE, Australia, Feb. 25, 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 ALMPS[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 enables healthcare providers in Luxembourg to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.
Illuccix, after radiolabelling with gallium-68, is indicated in Luxembourg 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/biochemical persistence (BCP)[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.
Illuccix's approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial[6]. With its broad indication and ready-to-use formulation, 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.
Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The approval of Illuccix® in Luxembourg will ensure this clinically validated PSMA-PET product is more widely available, allowing healthcare providers 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 technologies across Europe".
Notes to editors
- Healthcare professionals in Luxembourg interested in ordering Illuccix® or learning more about availability can contact customerservice.emea@telixpharma.com
Prostate Cancer in Luxembourg
Prostate cancer is the most common cancer for men in Luxembourg with over 440 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (177 new cases) or lung cancer (210 new cases). Prostate cancer is the third most common cause of cancer death in men in Luxembourg, with more than 60 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 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], and in multiple European Economic Area (EEA) Member States[12]. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM[13].
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, Canada, Europe (Luxembourg 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).
Telix's osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix's miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the EEA. No other Telix product has received a marketing authorization in any jurisdiction.
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.
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[1] Positron emission tomography. |
[2] Luxembourg Agency for Medicines and Health Products. |
[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 13 February 2025. |
[12] Denmark, Luxembourg, Malta and Norway at time of release. |
[13] Telix ASX disclosure 17 January 2025. |
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