Telix Pharmaceuticals Limited announces that its prostate cancer PET imaging agent Illuccix has been granted marketing authorization by the Swedish MPA 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 Sweden 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 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, CT scan) 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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Rimma Axelsson, MD, Professor of Nuclear Medicine at Karolinska Institutet, commented on the approval “We are seeing an increasing demand for PSMA-PET imaging in Sweden, reflecting a shift in how prostate cancer is managed and inclusion in national guidelines. The benefits of accurate, timely imaging are well recognized, and a flexible gallium-based tracer like Illuccix will support many centers in meeting this need. This includes where infrastructure is limited or access to a cyclotron is not available, for example with smaller PET clinics and in regional locations.”

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, “This approval in Sweden follows recent authorizations in Norway and Denmark and reflects our commitment to expanding access to advanced imaging across the Nordic region. We’re pleased to be working with Wiik Pharma to provide healthcare professionals with clinically proven tools that support earlier diagnosis and more precise treatment decisions, where and when they’re needed most.”

Prostate Cancer in Sweden

Prostate cancer is the most common cancer in Sweden overall and the most common cancer for Swedish men with over 11,700 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (4,037 new cases) or melanoma (2,697 new cases). Prostate cancer is also the most common cause of cancer death in men in Sweden, with over 2,400 men dying from their disease in 2022[7].

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Source – businesswire