Telix Pharmaceuticals Limited announces that its prostate cancer PETimaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by the Swedish MPAfor the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Sweden to offer PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical.Illuccix, after radiolabelling with gallium-68, is indicated in Sweden for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy.
Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CTscan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP). Illuccix® PSMA-PET will help fulfil a critical unmet need by facilitating access to timely and effective diagnosis and patient selection for treatment with 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.
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