Health Canada has approved Illuccix, a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of PSMA-positive lesions in patients with prostate cancer.1,2
Specifically, Illuccix is indicated for use in patients with suspected metastasis who are candidates for initial definitive therapy, or in patients with suspected recurrence based on elevated PSA level.
"On average, 67 men in Canada are diagnosed with prostate cancer each day. Early detection, along with better understanding of the spread and stage of the disease can lead to more informed disease management decisions. Tools such as Illuccix are valuable as we look for better ways to detect prostate cancer in men," Dr. Norman Laurin, current president of the Quebec Association of Nuclear Medicine Specialists and past president of the Canadian Association of Nuclear Medicine, stated in a press release.
68Ga PSMA-11 was previously approved in the United States for PET imaging of PSMA-positive lesions in men with prostate cancer.3 The approval was based on the safety and efficacy of the treatment proven in 2 prospective clinical trials with a total of 960 men with prostate cancer who each received 1 injection of the drug.
In the first trial, 325 patients who were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis underwent PET/CT or PET/MRI scans performed with 68Ga PSMA-11. Of the patients who went on to undergo surgery, 68Ga PSMA-11 demonstrated a clinically important rate of metastatic cancer confirmed by surgical pathology in patients with positive readings in the pelvic lymph nodes.
In the second trial, 635 patients who had rising serum PSA levels after initial prostate surgery or radiotherapy, 74% had at least 1 positive lesion detected by 68Ga PSMA-11 in at least 1 body region. In total, 91% of patients with positive 68Ga PSMA-11 readings who had correlative tissue pathology from biopsies, who also had results from baseline or follow-up imaging by conventional methods, and serial PSA levels available for comparison, also had local recurrence or metastasis of prostate cancer confirmed.
1. Health Canada Approves Illuccix® for Prostate Cancer Imaging. Published online October 13, 2022. Accessed October 18, 2022. https://prn.to/3D2uudt
2. FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix®. Published online December 19, 2021. Accessed October 18, 2022. https://bit.ly/3gh583M
3. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. Press release. FDA. December 1, 2020. Accessed December 1, 2020. https://bit.ly/3fWUOcN