Salute e Benessere
Illuccix® Receives European Approval
Kevin Richardson , Chief Executive Officer, Telix Precision Medicine commented, "We are delighted by this positive outcome, setting the stage for a European commercial launch of Illuccix. This clinically important prostate cancer imaging modality is currently recommended in international clinical practice guidelines including European Association of Urology (EAU) and European Society for Medical Oncology (ESMO)."
PSMA-PET imaging represents a major 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). European guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP) .
Telix's lead 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) , and by Health Canada .
In Europe , Illuccix, after radiolabelling with gallium-68, will be indicated for detection of PSMA-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings:
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 ( 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. 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 X and LinkedIn.
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
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