Melbourne (Australia) | 13 February 2025
Telix 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 PET[1] 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 imaging[2] represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT[3] 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 Canada[7], by the Danish Medicines Agency[8], and by the UK MHRA. Illuccix is currently in national approval review in 19 European countries following a positive decentralized procedure (DCP) opinion by BfArM[9].
To read the full ASX release, click here
[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.