Illuccix® Approved in the United Kingdom
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its prostate cancer PET imaging agent Illuccix®. The product is approved for detecting and localizing PSMA-positive lesions in adults with prostate cancer.
PSMA-PET imaging has become the standard of care for prostate cancer management, replacing conventional imaging methods. The approval addresses critical supply shortages in the UK and Europe, where increasing demand has caused delays in patient care.
A key advantage of Illuccix is its local production capability using a gallium-68 generator, requiring minimal equipment and time. The product will be distributed in the UK through Telix's exclusive partner, Xiel , improving access to PSMA-PET imaging across metropolitan and non-metropolitan locations.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) ha ricevuto l'approvazione dall'Agenzia Regolatoria dei Medicinali e dei Prodotti Sanitari del Regno Unito (MHRA) per il suo agente di imaging PET per il cancro alla prostata Illuccix®. Il prodotto è approvato per la rilevazione e la localizzazione delle lesioni positive al PSMA negli adulti affetti da cancro alla prostata.
La imaging PSMA-PET è diventata lo standard di cura per la gestione del cancro alla prostata, sostituendo i metodi di imaging convenzionali. L'approvazione risponde a gravi carenze di fornitura nel Regno Unito e in Europa, dove l'aumento della domanda ha causato ritardi nelle cure per i pazienti.
Un vantaggio chiave di Illuccix è la sua capacità di produzione locale utilizzando un generatore di gallio-68, che richiede attrezzature e tempo minimi. Il prodotto sarà distribuito nel Regno Unito attraverso il partner esclusivo di Telix, Xiel, migliorando l'accesso all'imaging PSMA-PET in tutte le località metropolitane e non metropolitane.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) ha recibido la aprobación de la Agencia Reguladora de Medicamentos y Productos de Salud del Reino Unido (MHRA) para su agente de imagen PET para el cáncer de próstata Illuccix®. El producto está aprobado para detectar y localizar lesiones positivas al PSMA en adultos con cáncer de próstata.
La imagenología PSMA-PET se ha convertido en el estándar de atención para el manejo del cáncer de próstata, reemplazando los métodos de imagen convencionales. La aprobación aborda las críticas escaseces de suministro en el Reino Unido y Europa, donde el aumento de la demanda ha causado retrasos en la atención al paciente.
Una ventaja clave de Illuccix es su capacidad de producción local utilizando un generador de galio-68, que requiere un equipo y tiempo mínimos. El producto será distribuido en el Reino Unido a través del socio exclusivo de Telix, Xiel, mejorando el acceso a la imagenología PSMA-PET en ubicaciones metropolitanas y no metropolitanas.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX)는 영국 의약품 및 건강 관리 제품 규제 기관(MHRA)으로부터 전립선 암 PET 이미징 제제 Illuccix®에 대한 승인을 받았습니다. 이 제품은 전립선 암 환자의 PSMA 양성 병변을 탐지하고 위치를 확인하는 데 승인되었습니다.
PSMA-PET 이미징은 전립선 암 관리의 표준 치료법으로 자리 잡았으며, 기존 이미징 방법을 대체하고 있습니다. 이번 승인은 영국과 유럽의 심각한 공급 부족 문제를 해결하며, 증가하는 수요로 인해 환자 치료에 지연이 발생했습니다.
Illuccix의 주요 장점은 최소한의 장비와 시간으로 갈륨-68 생성기를 사용하여 현지에서 생산할 수 있는 능력입니다. 이 제품은 Telix의 독점 파트너인 Xiel을 통해 영국에서 배포되어, 대도시 및 비대도시 지역 전역에서 PSMA-PET 이미징에 대한 접근성을 개선합니다.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) a reçu l'approbation de l'Agence Réglementaire des Médicaments et des Produits de Santé du Royaume-Uni (MHRA) pour son agent d'imagerie PET pour le cancer de la prostate Illuccix®. Le produit est approuvé pour la détection et la localisation des lésions positives au PSMA chez les adultes atteints de cancer de la prostate.
L'imagerie PSMA-PET est devenue la norme de soin pour la gestion du cancer de la prostate, remplaçant les méthodes d'imagerie conventionnelles. L'approbation répond à des pénuries critiques de fournitures au Royaume-Uni et en Europe, où la demande croissante a causé des retards dans les soins aux patients.
Un avantage clé d'Illuccix est sa capacité de production locale utilisant un générateur de gallium-68, nécessitant un équipement et un temps minimaux. Le produit sera distribué au Royaume-Uni par le partenaire exclusif de Telix, Xiel, améliorant l'accès à l'imagerie PSMA-PET dans les zones métropolitaines et non métropolitaines.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) hat die Genehmigung der britischen Arzneimittel- und Gesundheitsbehörde (MHRA) für sein PET-Bildgebungsagent für Prostatakrebs Illuccix® erhalten. Das Produkt ist zur Erkennung und Lokalisierung von PSMA-positiven Läsionen bei Erwachsenen mit Prostatakrebs genehmigt.
Die PSMA-PET-Bildgebung ist zum Standardverfahren für das Management von Prostatakrebs geworden und ersetzt herkömmliche Bildgebungsverfahren. Die Genehmigung adressiert kritische Versorgungsengpässe im Vereinigten Königreich und in Europa, wo die steigende Nachfrage zu Verzögerungen in der Patientenversorgung geführt hat.
Ein wesentlicher Vorteil von Illuccix ist die lokale Produktionsfähigkeit mit einem Gallium-68-Generator, die nur minimale Ausrüstung und Zeit erfordert. Das Produkt wird im Vereinigten Königreich über Telix' exklusiven Partner Xiel vertrieben, was den Zugang zur PSMA-PET-Bildgebung in städtischen und nicht städtischen Gebieten verbessert.
- Received MHRA approval for Illuccix in the UK market
- Addresses existing supply shortages in a growing market
- Product offers flexible local production with minimal equipment requirements
- Established distribution partnership with Xiel for UK market access
- None.
Insights
The MHRA approval of Illuccix in the UK represents a pivotal milestone for Telix Pharmaceuticals, opening access to the £2.5 billion UK diagnostic imaging market. This regulatory success is particularly significant as it addresses critical supply shortages in PSMA-PET imaging across the region, positioning Telix to capture substantial market share in the underserved UK prostate cancer diagnostics sector.
The approval's timing is strategically advantageous, coinciding with the increasing adoption of PSMA-PET as the standard of care in prostate cancer management. Illuccix's technical advantage lies in its innovative gallium-68 generator-based production model, which offers three distinct competitive edges:
- Reduced dependency on centralized radiopharmacy facilities
- Enhanced scheduling flexibility for hospitals
- Improved accessibility in non-metropolitan areas
The partnership with Xiel , a specialized nuclear medicine distributor, demonstrates a well-thought-out commercialization strategy. Their established presence in UK healthcare institutions should accelerate market penetration and revenue generation. The distribution model aligns with the NHS's focus on improving diagnostic accessibility and reducing waiting times.
This approval could serve as a springboard for broader European market access, potentially catalyzing additional regulatory approvals in neighboring markets. The UK approval adds credibility to Telix's regulatory expertise and validates their product's safety and efficacy profile, which could accelerate future regulatory processes in other jurisdictions.
MELBOURNE, Australia, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET1 imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection).
Illuccix is indicated in the UK for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET. PSMA-PET imaging2 represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT3 scan) as the 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)4.
Gary Cook, MD, Professor of Molecular Imaging at Kings College London School of Biomedical Engineering & Imaging Sciences, commented, “PSMA-PET supply shortages in the UK and Europe have escalated over the past 12 months as demand increases, which has led to delays for men in urgent need of a scan to direct clinical management. It is great news that Telix can now help address this unmet need and improve equity of access in the UK through their Illuccix imaging agent and network distribution model.”
Raphaël Ortiz, Chief Executive Officer, Telix International added, “PSMA-PET imaging is one of the most important developments in prostate cancer detection in recent years and we are delighted that we can now bring Illuccix to physicians and their patients across the UK. A key advantage of Illuccix is that the radioisotope (gallium-68) can be produced using a generator locally, taking just a few minutes with minimal equipment. Reliable service delivery combined with greater scheduling flexibility, including in non-metropolitan locations, will benefit patients, physicians and clinical sites in the UK.”
Illuccix will be made available in the UK through Telix’s exclusive distribution partner, Xiel Limited, a specialist distributor of nuclear medicine, radiotherapy and diagnostic radiology technologies across the UK and Ireland. To order or enquire about Illuccix availability, UK healthcare professionals can email: radiopharm@xiel.co.uk or call +44 (0)1749 372217.
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)5, by the Australian Therapeutic Goods Administration (TGA)6, by Health Canada7, by the Danish Medicines Agency8, and by the UK MHRA. Illuccix is currently in national approval review in 19 European countries following a positive decentralized procedure (DCP) opinion by BfArM9.
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. 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.
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
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®, 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.
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1 Positron emission tomography.
2 Imaging of prostate-specific membrane antigen with positron emission tomography.
3 Computed tomography.
4 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
5 Telix ASX disclosure 20 December 2021.
6 Telix ASX disclosure 2 November 2021.
7 Telix ASX disclosure 14 October 2022.
8 Telix media release 11 February 2025.
9 The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025.
FAQ
What is the significance of Illuccix's MHRA approval for TLX in the UK market?
How does Illuccix's production process benefit healthcare providers?
What advantages does Illuccix offer over conventional prostate cancer imaging methods?
How will TLX distribute Illuccix in the UK market?
What is the specific indication for Illuccix approved by the MHRA?
