New approval provides French hospitals and clinics with access to a proven PSMA-PET imaging agent
MELBOURNE, Australia, April 29, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its prostate cancer PET1 imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in France by ANSM2 for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label.
Illuccix, after radiolabelling with gallium-68, is indicated in France 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-PET3 imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT4 scan) thereby offering a new standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognise its superior accuracy in staging primary disease and assessing BCR/biochemical persistence (BCP)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 trial6. The approval of Illuccix® in France has the potential to resolve access challenges by enabling hospitals and clinics to prepare PSMA-PET scans on-site, offering physicians a quicker, more accessible solution.
Professor Frédéric Courbon, Head of the Medical Imaging Department - University Cancer Institute of Toulouse – Oncopole, commented, “PSMA-PET imaging is dramatically changing prostate cancer patient management. Thus, equitable and reliable access to PSMA-PET across France is essential.The approval of Illuccix® in France will address some of the access challenges, and reduce the risk of delayed diagnosis, with a readily available option for effective disease management."
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.
“The approval of Illuccix in France will enable a clinically validated PSMA-PET product to be more widely available, allowing healthcare providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces our ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe,” said Raphaël Ortiz, Chief Executive Officer, Telix International.
Telix will partner with IRE ELiT S.A. (the radiopharmaceutical subsidiary of IRE Group), a leading provider of radioisotopes and radiopharmaceuticals for nuclear medicine, for the marketing and promotion of Illuccix® to healthcare professionals in France.
Jean Bonnet, Head of Strategy, Sales and Marketing, IRE EliT added: "We are pleased to collaborate with Telix and bring our expertise to expanding the availability of Illuccix throughout France. We are committed to ensuring that clinicians have access to reliable PSMA-PET imaging technologies to improve the lives of people living with prostate cancer."
Notes to editors
French healthcare professionals interested in ordering Illuccix® or learning more about availability can contact Eric Rizzo: eric.rizzo@ire-elit.eu
Prostate Cancer in France
Prostate cancer is the most common cancer in men in France, with over 57,000 new cases diagnosed annually, and a significantly higher incidence in men than either lung cancer (32,800 new cases) or bowel cancer (27,000 new cases). Prostate cancer is also a common cause of cancer death in men, with over 9,200 men dying from their disease in France in 20227.
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 Canada10, by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)11, by the French ANSM, and in multiple other European Economic Area (EEA) Member States12. Illuccix® is currently in national approval review across the European Economic Area following a positive decentralized procedure (DCP) opinion by BfArM13.
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).
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 European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction.
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1 Positron emission tomography. 2 National Agency for the Safety of Medicine and Health Products (Agence nationale de sécurité du médicament et des produits de santé). 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 Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release. 13 The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025.
