Full Press Release Details
Melbourne (Australia) and Liège (Belgium) | 17 January 2025
Telix 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] .
About Illuccix®
Telix’s lead imaging product, gallium-68 ( 68 Ga) gozetotide injection (also known as 68 Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA) [9] , by the Australian Therapeutic Goods Administration (TGA) [10] , and by Health Canada [11] .
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:
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[1] Positron emission tomography.
[2] The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte).
[3] Germany serves as the Reference Member State in the Decentralised Procedure. The other 18 Concerned Member States are Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, and Sweden.
[4] Regulatory approval timeframe from EEA CMSs may vary considerably.
[5] Imaging of prostate-specific membrane antigen with positron emission tomography.
[6] Computed tomography.
[7] EAU, ESMO.
[8] EAU.
[9] Telix ASX disclosure 20 December 2021.
[10] Telix ASX disclosure 2 November 2021.
[11] Telix ASX disclosure 14 October 2022.