Salute e Benessere
Illuccix® Prostate Cancer Imaging Agent Approved in Luxembourg
PSMA-PET imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT scan) thereby offering a new 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 approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial . With its broad indication and ready-to-use formulation, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe , reinforcing the need for solutions that fit within existing hospital workflows.
Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The approval of Illuccix® in Luxembourg will ensure this clinically validated PSMA-PET product is more widely available, allowing healthcare providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces Telix's ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe ".
Prostate cancer is the most common cancer for men in Luxembourg with over 440 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (177 new cases) or lung cancer (210 new cases). Prostate cancer is the third most common cause of cancer death in men in Luxembourg , with more than 60 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) , 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 ,
Canada , Europe ( Luxembourg 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 ( Tc) 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 EEA. 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.
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
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