Health Canada approves expanded indication of Illuccix in prostate cancer

Health Canada has approved an expanded indication of Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection; TLX591-CDx) to allow for use in the selection of patients with metastatic castration-resistant prostate cancer (mCRPC) for PSMA-targeted radionuclide therapy with ¹⁷⁷Lu-PSMA-617 (lutetium (¹⁷⁷Lu) vipivotide tetraxetan; Pluvicto), Telix Pharmaceuticals announced in a news release.¹

TLX591-CDx also received initial US FDA approval in December 2021.

The cold kit was initially approved in Canada in October 2022 for use in the staging and re-staging of intermediate- and high-risk prostate cancer and for localizing tumor tissue in recurrent prostate cancer. Illuccix, after radiolabeling with ⁶⁸Ga, is indicated for use with PET imaging of PSMA-positive lesions in men with suspected metastasis who are suitable for initial definitive therapy and for men with suspected recurrence based on elevated prostate specific antigen (PSA) levels.

Illuccix also received US FDA approval for the same initial indications in December 2021. The FDA granted approval to the expanded indication of Illuccix in March 2023 to allow for use in patient selection for PSMA-targeted radioligand therapy.²

“We welcome Health Canada’s decision to expand the label for Illuccix,” said Kevin Richardson, CEO of Telix Precision Medicine, in the news release.¹ “This will further improve access to advanced prostate cancer imaging and provide doctors with critical information to help make treatment decisions with confidence. This reflects Telix’s ongoing commitment to supporting patients with cancer and empowering the doctors who care for them across more stages of the patient journey.”

In the phase 3 VISION trial (NCT03511664), Illuccix was utilized to help identify patients appropriate for treatment with ¹⁷⁷Lu-PSMA-617. Data from the trial supported FDA approval of ¹⁷⁷Lu-PSMA-617 in March 2022 for the treatment of patients with PSMA-positive mCRPC.³

“As targeted radionuclide therapy for prostate cancer becomes more prevalent in Canada, it is critical for doctors to understand who may or may not respond to those treatments,” added Dr. Francois Lamoureux, President of the Canadian Association of Nuclear Medicine, in the news release.¹ “In the VISION trial, ⁶⁸Ga-PSMA-11 PET/CT was shown to be a powerful and highly accurate tool for detecting prostate cancer and informing patient management.”

Overall, data from the VISION trial demonstrated that treatment with ¹⁷⁷Lu-PSMA-617 plus standard of care extended imaging-based progression-free survival (PFS) and overall survival (OS) in patients with PSMA-positive mCRPC.⁴ PSMA-positive status in the study was determined by ⁶⁸Ga-PSMA-11 PET/CT scans.

At a median follow-up of 20.9 months, the median PFS with ¹⁷⁷Lu-PSMA-617 plus standard care was 8.7 months, compared with 3.4 months with standard care alone (HR, 0.40; 99.2% CI, 0.29 to 0.57; P < .001). Similarly, the median OS was 15.3 months with ¹⁷⁷Lu-PSMA-617 plus standard care vs 11.3 months with standard care alone (HR, 0.62; 95% CI, 0.52 to 0.74; P < .001).

Results from the trial’s key secondary end points of objective response, disease control, and time to symptomatic skeletal events also favored the ¹⁷⁷Lu-PSMA-617 plus standard care arm.

Regarding safety, 52.7% of patients in the ¹⁷⁷Lu-PSMA-617 plus standard care arm experienced an adverse event of grade 3 or higher compared with 38.0% of patients in the standard care alone arm. Quality of life did not appear to be adversely affected in the ¹⁷⁷Lu-PSMA-617 cohort.

In total, the international, open-label trial included 831 patients with a PSMA-positive metastatic lesion who were randomly assigned 2:1 to receive ¹⁷⁷Lu-PSMA-617 plus standard care or standard care alone. Baseline characteristics were well-balanced between the 2 arms. The primary end points were imaging-based PFS and OS.

References

1. Health Canada approves label expansion for Telix’s Illuccix to include patient selection for PSMA-targeted therapy. News release. Telix Pharmaceuticals. October 4, 2024. Accessed October 7, 2024. https://telixpharma.com/news-views/health-canada-approves-label-expansion-for-telixs-illuccix-to-include-patient-selection-for-psma-targeted-therapy/

2. FDA approves expanded indication for Telix’s Illuccix to include patient selection for PSMA-directed radioligand therapy. News release. Telix Pharmaceuticals. March 16, 2023. Accessed October 7, 2024. https://telixpharma.com/news-views/fda-approves-expanded-indication-for-telixs-illuccix-to-include-patient-selection-for-psma-directed-radioligand-therapy/

3. FDA approves Pluvicto for metastatic castration-resistant prostate cancer. News release. US Food & Drug Administration. March 23, 2022. Accessed October 7, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer

4. Sartor O, de Bono J, Chi KN, et al. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi:10.1056/NEJMoa2107322