MELBOURNE, Australia,June 5, 2025/PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that its prostate cancer PET[1]imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization inGermanyby BfArM[2]for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enhances the options available to healthcare providers acrossGermanyfor PSMA-PET[3]imaging and will ensure more patients can access this essential diagnostic tool.
Illuccix, after radiolabelling with gallium-68, is indicated inGermanyfor the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings:
- Primary staging of patients with high-risk PCa prior to primary curative therapy.
- Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy.
- Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.
PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods such as bone scans and CT[4]scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognize its superior accuracy in staging primary disease and assessing BCR[5]. Illuccix® PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from 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[6]. Despite the proven benefits of PSMA-PET imaging, men inGermanyhave faced long wait times due to tracer shortages and infrastructure constraints. Illuccix® has the potential to resolve these access challenges by enabling hospitals and clinics to prepare PSMA-PET scans on-site, freeing physicians to manage other important duties and focus on patient needs.
In particular, in settings where there is a reliance on fluorine-18 (18F) tracers, the availability of Illuccix®, a GMP-quality prostate cancer imaging product, will help to avoid delivery delays and other logistical barriers, improving access.
Professor Ken Herrmann, Chair of the Department of Nuclear Medicine at University Hospital Essen, commented, "PSMA-PET imaging has changed how we detect and monitor prostate cancer, offering greater accuracy and confidence in treatment planning. However, limited availability has meant that many patients face delays in accessing this essential diagnostic tool. The approval of Illuccix® inGermanyis an important development, ensuring that more hospitals can integrate this imaging technology into routine clinical practice."
With its broad indication, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow acrossEurope, reinforcing the need for solutions that fit within existing hospital workflows.
"We are pleased that Illuccix® has been approved inGermanywith a broad label that reflects its clinical value at multiple stages of prostate cancer care.Germanyhas played a key role in the advancement of PSMA-PET imaging, and this approval ensures that physicians now have access to Telix's gallium-based PSMA-PET imaging agent, which offers high diagnostic accuracy alongside the efficiency and flexibility of generator-produced gallium. This milestone reflects our commitment to expanding access to world-class prostate cancer imaging solutions acrossEurope" said Raphaël Ortiz, Chief Executive Officer, Telix International.
Illuccix® will be distributed inGermanyby Eckert & Ziegler SE, a leading provider of nuclear medicine and diagnostic imaging solutions.
Dr.Harald Hasselmann, Chief Executive Officer of Eckert & Ziegler SE added: "Our collaboration with Telix on Illuccix® leverages our established distribution network and market expertise to ensure broad access to this important PSMA-PET imaging agent for German physicians and their patients. This partnership reinforces our commitment to delivering advanced diagnostic solutions for improved prostate cancer care."
German healthcare professionals interested in ordering Illuccix® or learning more about availability can email[email protected]or call + 49 30 941084 280.
Prostate Cancer inGermany
Prostate cancer is the most common cancer in men inGermany, with over 65,000 new cases diagnosed annually, and a significantly higher incidence in men than either lung cancer (37,000 new cases) or bowel cancer (33,000 new cases). Prostate cancer was also the second most common cause of cancer death in men, with over 18,000 men dying from their disease inGermanyin 2022[7].
About Illuccix®
Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the United States Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the Brazilian Health Regulatory Agency (ANVISA)[11], by theUnited Kingdom(UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[12], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[13], by the German Federal Institute for Drugs and Medical Devices (BfArM), and in multiple other countries within the European Economic Area (EEA)[14]following a positive decentralized procedure (DCP) opinion by the German medical regulator[15].
AboutTelix 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 inMelbourne, Australia, with international operations inthe United States,Brazil,Canada,Europe(BelgiumandSwitzerland), andJapan. 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).
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