Illuccix® Receives European Approval
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received European approval for Illuccix®, its prostate cancer PET imaging agent. The approval comes through a positive decision on the Marketing Authorization Application (MAA) via a decentralized procedure (DCP), following the Final Assessment Report from the German Competent Authority BfArM.
The approval covers all 18 European Economic Area (EEA) Concerned Member States, with the process now moving to an administrative national phase for individual country launches. PSMA-PET imaging, which Illuccix facilitates, has become the standard of care for prostate cancer management, replacing conventional imaging methods. The technology is recommended in international clinical practice guidelines, including those of the European Association of Urology (EAU) and European Society for Medical Oncology (ESMO).
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) ha ricevuto l'approvazione europea per Illuccix®, il suo agente di imaging PET per il cancro alla prostata. L'approvazione arriva grazie a una decisione positiva sulla Domanda di Autorizzazione alla Commercializzazione (MAA) tramite una procedura decentralizzata (DCP), a seguito del Rapporto di Valutazione Finale dell'Autorità Competente tedesca BfArM.
L'approvazione copre tutti i 18 Stati Membri della Zona Economica Europea (ZEE) coinvolti, con il processo che ora passa a una fase nazionale amministrativa per i lanci nei singoli Paesi. Imaging PSMA-PET, che Illuccix facilita, è diventato lo standard di cura per la gestione del cancro alla prostata, sostituendo i metodi di imaging convenzionali. La tecnologia è raccomandata nelle linee guida di pratica clinica internazionali, incluse quelle dell'Associazione Europea di Urologia (EAU) e della Società Europea di Oncologia Medica (ESMO).
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) ha recibido la aprobación europea para Illuccix®, su agente de imagen PET para el cáncer de próstata. La aprobación llega a través de una decisión positiva sobre la Solicitud de Autorización de Comercialización (MAA) mediante un procedimiento descentralizado (DCP), tras el Informe de Evaluación Final de la Autoridad Competente alemana BfArM.
La aprobación abarca los 18 Estados Miembros de la Zona Económica Europea (EEE) involucrados, y el proceso ahora pasa a una fase administrativa nacional para los lanzamientos en los países individuales. La imagenología PSMA-PET, que facilita Illuccix, se ha convertido en el estándar de atención para la gestión del cáncer de próstata, reemplazando los métodos de imagen convencionales. La tecnología es recomendada en las guías de práctica clínica internacionales, incluidas las de la Asociación Europea de Urología (EAU) y la Sociedad Europea de Oncología Médica (ESMO).
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX)가 전립선암 PET 이미징제 Illuccix®에 대한 유럽 승인을 받았습니다. 이 승인은 독일 권한 기관 BfArM의 최종 평가 보고서를 기반으로 한 분산 절차(DCP)를 통해 마케팅 승인 신청서(MAA)에 대한 긍정적인 결정 덕분에 이루어졌습니다.
승인은 18개의 유럽 경제 지역(EEA) 관련 회원국을 모두 포함하며, 이제 개별 국가 출시를 위한 행정적 국가 단계로 넘어갑니다. PSMA-PET 이미징은 Illuccix가 가능하게 하며, 전통적인 이미징 방법을 대체하여 전립선암 관리의 표준 치료법이 되었습니다. 이 기술은 유럽 비뇨기학회(EAU) 및 유럽 медицин oncology 협회(ESMO)를 포함한 국제 임상 실무 지침에서 추천됩니다.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) a reçu l'approbation européenne pour Illuccix®, son agent d'imagerie PET pour le cancer de la prostate. L'approbation a été accordée suite à une décision positive concernant la Demande d'Autorisation de Mise sur le Marché (MAA) dans le cadre d'une procédure décentralisée (DCP), à la suite du Rapport d'Évaluation Final de l'Autorité Compétente Allemande BfArM.
Cette approbation couvre tous les 18 États membres concernés de l'Espace Économique Européen (EEE), le processus passant maintenant à une phase nationale administrative pour le lancement dans chaque pays. L'imagerie PSMA-PET, que facilite Illuccix, est devenue le standard de soins pour la gestion du cancer de la prostate, remplaçant les méthodes d'imagerie conventionnelles. La technologie est recommandée dans les directives de pratiques cliniques internationales, y compris celles de l'Association Européenne d'Urologie (EAU) et de la Société Européenne d'Oncologie Médicale (ESMO).
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) hat die europäische Zulassung für Illuccix®, sein PET-Bildgebungsagent für Prostatakrebs, erhalten. Die Zulassung erfolgt durch eine positive Entscheidung über den Antrag auf Marktzulassung (MAA) im Rahmen eines dezentralen Verfahrens (DCP), nach dem Abschlussbewertungsbericht der deutschen zuständigen Behörde BfArM.
Die Zulassung umfasst alle 18 Mitgliedstaaten des Europäischen Wirtschaftsraums (EWR), wobei der Prozess jetzt in eine administrative nationale Phase für die einzelnen Ländereinführungen übergeht. PSMA-PET-Bildgebung, die Illuccix ermöglicht, hat sich zum Standard der Versorgung für das Management von Prostatakrebs entwickelt und ersetzt konventionelle Bildgebungsverfahren. Die Technologie wird in internationalen klinischen Praxisleitlinien empfohlen, einschließlich derjenigen der Europäischen Urologiegesellschaft (EAU) und der Europäischen Gesellschaft für Medizinische Onkologie (ESMO).
- Received European marketing authorization approval for Illuccix
- Authorization covers 18 European Economic Area markets
- Product aligned with current clinical practice guidelines
- Technology represents new standard of care in prostate cancer imaging
- None.
Insights
The European regulatory approval for Illuccix® represents a major market expansion opportunity for Telix Pharmaceuticals. With authorization across 18 EEA member states, this opens access to a significant prostate cancer diagnostics market. The decentralized procedure approval, with Germany's BfArM as the reference authority, provides a streamlined path to commercialization across multiple European territories.
For context in simple terms: Think of this like getting a master key that unlocks 18 different doors (countries) at once, instead of having to get separate keys for each door. This makes the market entry process much more efficient.
This approval is particularly valuable as PSMA-PET imaging is already embedded in European clinical guidelines (EAU and ESMO), meaning there's an established clinical need and acceptance among healthcare providers. This pre-existing guideline inclusion should accelerate market adoption and reimbursement processes.
The significance of this approval extends beyond mere market access. PSMA-PET imaging represents a paradigm shift in prostate cancer management, offering superior diagnostic accuracy compared to conventional imaging methods. This technology's ability to detect both primary disease staging and biochemical recurrence provides clinicians with more precise diagnostic tools, potentially leading to better-informed treatment decisions.
To simplify: Traditional imaging methods (like CT scans) are like looking at a map of a city from far away - you see the big picture but miss important details. PSMA-PET is like having a high-definition satellite view that can zoom in to show specific buildings (cancer cells) with much greater clarity.
The inclusion in both EAU and ESMO guidelines indicates strong clinical validation and suggests likely favorable reimbursement decisions across European healthcare systems, which is important for commercial success.
MELBOURNE, Australia and LIÈGE, Belgium, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate cancer PET1 imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection), which was submitted in Europe via a decentralized procedure (DCP).
This significant milestone follows the issuance of the Final Assessment Report from the German Competent Authority BfArM2 as Reference Member State (RMS). Through the DCP, the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS)3 agree that Illuccix should receive marketing authorization. The DCP regulatory process will now transition into an administrative national phase to implement authorizations to facilitate commercial launch in each country4.
Kevin Richardson, Chief Executive Officer, Telix Precision Medicine commented, “We are delighted by this positive outcome, setting the stage for a European commercial launch of Illuccix. This clinically important prostate cancer imaging modality is currently recommended in international clinical practice guidelines including European Association of Urology (EAU) and European Society for Medical Oncology (ESMO).”
PSMA-PET imaging5 represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT6 scan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). European guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease7 and evaluation of BCR/biochemical persistence (BCP)8.
About Illuccix®
Telix’s lead 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)9, by the Australian Therapeutic Goods Administration (TGA) 10, and by Health Canada11.
In Europe, Illuccix, after radiolabelling with gallium-68, will be indicated for detection of 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.
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 (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 X and LinkedIn.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
1 Positron emission tomography.
2 The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte).
3 Germany serves as the Reference Member State in the Decentralised Procedure. The other 18 Concerned Member States are Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, and Sweden.
4 Regulatory approval timeframe from EEA CMSs may vary considerably.
5 Imaging of prostate-specific membrane antigen with positron emission tomography.
6 Computed tomography.
7 EAU, ESMO.
8 EAU.
9 Telix ASX disclosure 20 December 2021.
10 Telix ASX disclosure 2 November 2021.
11 Telix ASX disclosure 14 October 2022.
FAQ
What European approval did Telix (TLX) receive for Illuccix in January 2024?
How many European countries will Illuccix be available in after TLX's approval?
What medical guidelines recommend Telix's Illuccix PSMA-PET imaging?
What conventional imaging methods does TLX's Illuccix PSMA-PET replace?
