Salute e Benessere
Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in Sweden
PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT 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) . Illuccix® PSMA-PET will help fulfil a critical unmet need by facilitating access to timely and effective diagnosis and patient selection for treatment with 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 trial .
Rimma Axelsson , MD, Professor of Nuclear Medicine at Karolinska Institutet, commented on the approval "We are seeing an increasing demand for PSMA-PET imaging in Sweden , reflecting a shift in how prostate cancer is managed and inclusion in national guidelines. The benefits of accurate, timely imaging are well recognized, and a flexible gallium-based tracer like Illuccix will support many centers in meeting this need. This includes where infrastructure is limited or access to a cyclotron is not available, for example with smaller PET clinics and in regional locations."
Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "This approval in Sweden follows recent authorizations in Norway and Denmark and reflects our commitment to expanding access to advanced imaging across the Nordic region. We're pleased to be working with Wiik Pharma to provide healthcare professionals with clinically proven tools that support earlier diagnosis and more precise treatment decisions, where and when they're needed most."
Illuccix® will be made available in Sweden through Telix's distribution partner for the Nordic region, Wiik Pharma ApS (Wiik Pharma), a specialist supplier and distributor of nuclear medicine products and services. To order or enquire about Illuccix® availability, authorized healthcare professionals in Sweden can email: info@wiikpharma.dk or call +45 5389 9010.
Prostate cancer is the most common cancer in Sweden overall and the most common cancer for Swedish men with over 11,700 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (4,037 new cases) or melanoma (2,697 new cases). Prostate cancer is also the most common cause of cancer death in men in Sweden , with over 2,400 men dying from their disease in 2022 .
Telix's prostate imaging product, gallium-68 ( Ga) gozetotide injection (also known as Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA) , by the Australian Therapeutic Goods Administration (TGA) , by Health Canada , by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) , by the Brazilian Health Regulatory Agency (ANVISA) , and in multiple European Economic Area (EEA) Member States . Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM .
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).
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.
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
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