Telix Pharmaceuticals Limited’s prostate cancer PET imaging agent, Illuccix (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Germany by BfArM for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enhances the options available to healthcare providers across Germany for PSMA-PET imaging and will ensure more patients can access this diagnostic tool.

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

Illuccix was also approved by the Danish Medicines Agency earlier this year.

PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods such as bone scans and CT scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognize its superior accuracy in staging primary disease and assessing BCR. Illuccix PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy.