• Illuccix, Telix's prostate cancer PET imaging agent, receives European marketing authorization
• Illuccix is approved for primary staging, suspected recurrence, and identification of patients with PSMA-positive mCRPC
• European approval follows previous approvals in the US, Australia, and Canada

Telix Pharmaceuticals Limited has announced that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate cancer PET imaging agent Illuccix (kit for the preparation of gallium-68 gozetotide injection) in Europe. This significant milestone follows the issuance of the Final Assessment Report from the German Competent Authority BfArM as the Reference Member State. Through the decentralized procedure, the Reference Member State and all 18 European Economic Area Concerned Member States have agreed that Illuccix should receive marketing authorization. The regulatory process will now transition into an administrative national phase to implement authorizations in each country. Illuccix, after radiolabelling with gallium-68, will be indicated for the detection of PSMA-positive lesions with PET in adults with prostate cancer in the following clinical settings: primary staging of patients with high-risk prostate cancer prior to primary curative therapy, suspected recurrent prostate cancer in patients with increasing levels of serum prostate-specific antigen after primary curative therapy, and identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer for whom PSMA-targeted therapy is indicated. This European approval follows previous approvals of Illuccix by the U.S. Food and Drug Administration, the Australian Therapeutic Goods Administration, and Health Canada.

The European approval of Illuccix sets the stage for a commercial launch of the product across the European Economic Area, further expanding Telix's global footprint and providing a clinically important prostate cancer imaging modality to healthcare providers and patients in Europe.