Telix Pharmaceuticals Ltd.’s prostate cancer PET imaging agent Illuccix has been approved by the Danish Medicines Agency.

Illuccix, after radiolabelling with gallium-68, is indicated in Denmark 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 is a major advancement in prostate cancer care, replacing conventional methods like bone and CT scans after diagnosis and biochemical recurrence (BCR). Global guidelines underscore PSMA-PET’s superior accuracy for staging primary disease and assessing BCR/biochemical persistence (BCP). Illuccix PSMA-PET addresses an unmet need for timely diagnosis and patient selection for PSMA-targeted therapy.

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, “We are delighted that Illuccix has been approved in Denmark with this broad label demonstrative of clinical utility at multiple critical points in the prostate cancer journey. Danish physicians and their patients will now have access to Telix’s innovative gallium-based PSMA-PET imaging agent, along with the efficiencies and scheduling flexibility of generator-produced gallium.”

Illuccix will be made available in Denmark through Telix’s distribution partner for the Nordic region, WIIK Pharma ApS (WIIk Pharma).

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