Telix Pharmaceuticals Limited announces that its prostate cancer PET imaging agent Illuccix has been granted marketing authorization by Fimea for 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 Finland to offer PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical.

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Illuccix, after radiolabelling with gallium-68, is indicated in Finland 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.

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PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods 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)[5]. 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.

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, “Telix is committed to supporting people living with prostate cancer by working to improve access to accurate and reliable diagnostic imaging. The approval of Illuccix in Finland reflects the increasing importance of PSMA-PET in clinical decision-making. In partnership with our distributor, WIIk Pharma, we are focused on ensuring that healthcare providers across Finland can access a clinically validated imaging solution that is both effective and practical to implement. This milestone reinforces our ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe”.

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Source – PR Newswire