Health Canada Approves Illuccix® for mCRPC

Telix has announced that Health Canada has approved Illuccix® (gallium Ga 68 gozetotide injection kit) for use in selecting patients eligible for PSMA-targeted radionuclide therapy. This label expansion allows Illuccix to be used in Canada for identifying patients with progressive metastatic castration-resistant prostate cancer (mCRPC) who are candidates for treatment with the only approved PSMA-targeted radionuclide therapy, lutetium (177Lu) vipivotide tetraxetan, known as Pluvicto®.

Illuccix has been approved in Canada since October 2022 for staging and re-staging intermediate and high-risk prostate cancer, as well as localizing tumor tissue in recurrent cases. It is distributed nationwide through Telix's partner, Isologic Innovative Radiopharmaceuticals, which services 265 hospitals and clinics across the country.

Dr. Francois Lamoureux, President of the Canadian Association of Nuclear Medicine, emphasized the importance of understanding which patients may benefit from targeted radionuclide therapies, highlighting the accuracy of the 68Ga-PSMA-11 PET/CT imaging used in the VISION trial for prostate cancer detection.

André Gagnon, President of Isologic, noted that PSMA-targeted theranostics represent the future of prostate cancer treatment, making the approval for Illuccix in this new context particularly significant.

Kevin Richardson, CEO of Telix Precision Medicine, welcomed Health Canada’s decision, stating it enhances access to advanced imaging for prostate cancer and supports doctors in making informed treatment decisions. This aligns with Telix’s commitment to aiding cancer patients and empowering their healthcare providers throughout various stages of treatment.

Indications for Illuccix in Canada include its use in PET imaging of PSMA-positive lesions in men with prostate cancer, including those suspected of having metastasis suitable for definitive therapy, those with suspected recurrence and elevated PSA levels, and those with progressive mCRPC requiring PSMA-targeted therapy. Illuccix is classified as a Schedule C radiopharmaceutical product and has also received approvals from the U.S. FDA and the Australian TGA.