Illuccix is approved by Health Canada for imaging in patients with suspected metastasis who are candidates for initial definitive therapy, or in patients with suspected recurrence based on an elevated PSA level.
The first patients in a commercial setting in Canada have been imaged with Illuccix, a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer.1,2
The commercial launch follows the approval of Illuccix by Health Canada in October 2022. The agency approved Illuccix for imaging in patients with suspected metastasis who are candidates for initial definitive therapy, or in patients with suspected recurrence based on an elevated PSA level.
"The launch of Illuccix in Canada marks an important milestone for Telix and the approximately 24,000 men who will be diagnosed with prostate cancer in the country this year. Widespread availability of PSMA-PET imaging, via Telix's distribution partner Isologic, will help deliver on a significant unmet medical need for the men in Canada and their families affected by this disease,” Kevin Richardson, chief executive officer for Telix Americas, stated in a press release.
Evidence of the efficacy of 68Ga PSMA-11 has been demonstrated in clinical trials, including 2 prospective trials with a total of 960 men with prostate cancer who each received 1 injection of the agent.3
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. First Patients in Canada Imaged with Illuccix®: Now Commercially Available Nationwide. Published online May 1, 2023. https://prn.to/3pcLDOe
2. 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