Telix's Illuccix® PSMA-PET Imaging Agent Approved in Portugal
07.08.2025 - 18:07:13Prostate Cancer in Portugal
Prostate cancer is the most common cancer in men in Portugal, with just over 7,500 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (6,092 new cases) or lung cancer (4,253 new cases). Prostate cancer is also the third most common cause of cancer death in men, with just over 2,080 men dying from their disease in Portugal in 2022[8].
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 United States Food and Drug Administration (FDA)[9], by the Australian Therapeutic Goods Administration (TGA)[10], by Health Canada[11], by the Brazilian Health Regulatory Agency (ANVISA)[12], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[13], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[14] and in multiple countries within the European Economic Area (EEA)[15] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[16].
About Telix 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 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.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
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[1] Positron emission tomography.
[2] National Authority of Medicines and Health Products, I.P.
[3] Imaging of prostate-specific membrane antigen with positron emission tomography.
[4] Computed tomography.
[5] European Association of Urology (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: European Society for Medical Oncology (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
[6] ClinicalTrials.gov ID: NCT03511664. VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for PSMA-PET imaging.
[7] GalliaPharm® is a registered trademark of Eckert & Ziegler SE.
[8] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.
[9] Telix ASX disclosure 20 December 2021.
[10] Telix ASX disclosure 2 November 2021.
[11] Telix ASX disclosure 14 October 2022.
[12] Telix ASX disclosure 18 March 2025.
[13] Telix ASX disclosure 13 February 2025.
[14] Telix media release 29 April 2025.
[15] Czech Republic, Denmark, Finland, Ireland, Luxembourg, Malta, the Netherlands, Norway, Portugal and Sweden at time of release.
[16] Telix ASX disclosure 17 January 2025.
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