Salute e Benessere
Telix's Illuccix® PSMA-PET Imaging Agent Approved in Portugal
PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods such as bone scans and CT scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognise its superior accuracy in staging primary disease and assessing BCR . 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 . Despite the proven benefits of PSMA-PET imaging, patients in Portugal have faced long wait times due to tracer shortages and infrastructure constraints.
Dr. Fernando Abreu , Director of Nuclear Medicine at the Santa Maria Local Health Unit, commented,
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 across Europe , reinforcing the need for solutions that fit within existing hospital workflows.
Illuccix® will be distributed in Portugal by Sociedade Avanço, Unipessoal, LDA (Avanço), a specialist distributor of nuclear medicine, radiotherapy technologies and urology biopsy products.
said Raphaël Ortiz, Chief Executive Officer, Telix International.
Mr. Diogo Marcos , Managing Director of Avanço added: " "
Healthcare professionals in Portugal interested in ordering Illuccix® or learning more about availability can contact comercial@ams.pt or call (+351) 214 380 690.
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 .
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 United States Food and Drug Administration (FDA) , by the Australian Therapeutic Goods Administration (TGA) , by Health Canada , by the Brazilian Health Regulatory Agency (ANVISA) , by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) , by the French National Agency for the Safety of Medicine and Health Products (ANSM) and in multiple countries within the European Economic Area (EEA) following a positive decentralized procedure (DCP) opinion by the German medical regulator, 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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