Illuccix® Receives European Approval

MELBOURNE, Australia and LIÈGE, Belgium, Jan. 17, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection), which was submitted in Europe via a decentralized procedure (DCP).

This significant milestone follows the issuance of the Final Assessment Report from the German Competent Authority BfArM[2] as Reference Member State (RMS). Through the DCP, the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS)[3] agree that Illuccix should receive marketing authorization. The DCP regulatory process will now transition into an administrative national phase to implement authorizations to facilitate commercial launch in each country[4].

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[5] represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT[6] 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[7] and evaluation of BCR/biochemical persistence (BCP)[8].

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