News & Views

Telix today announces that its next-generation PSMA-PET imaging agent for prostate cancer, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), is now commercially available nationally in the United States (U.S.).

Telix today announces that its prostate cancer PET[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Germany by BfArM[2] 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[3] imaging, and will ensure more patients can access this essential diagnostic tool.

Telix today announces that its prostate cancer PET imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Portugal by INFARMED 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 Portugal for PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical.

Telix advises that it has evaluated the Executive Order issued by the United States (U.S.) Government to implement a “Most-Favored Nation” (MFN) policy around drug pricing. Based on currently available information, there is a low likelihood of material impact to Telix’s business.

Telix today announces that that the pivotal Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Chinese patients has completed patient enrolment.