Illuccix® Gains Approval in the UK

Telix Pharmaceuticals Limited 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 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.