Illuccix approved in Europe for detection of PSMA-positive lesions

European regulatory authorities have issued a positive decision to a marketing authorization application for Illuccix, after radiolabeling with gallium (Ga)-68 gozetotide injection, for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adult patients with prostate cancer, Telix Pharmaceuticals announced in a news release.¹

In the VISION trial, Illuccix helped identify patients appropriate for treatment with ¹⁷⁷Lu-PSMA-617.

Specifically, Illuccix is indicated in the primary staging of patients with high-risk prostate cancer prior to primary curative therapy, for suspected recurrent prostate cancer in patients who have rising prostate-specific antigen (PSA) levels following primary curative therapy, and in the identification of patients with PSMA-positive progression metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.

This approval follows a Final Assessment Report from the German Competent Authority BfArM as a Reference Member State (RMS). In this report, the RMS and 18 European Economic Area Concerned Member States all agreed on granting marketing authorization to Illuccix. Commerical launch of the agent will now follow in each country.

"We are delighted by this positive outcome, setting the stage for a European commercial launch of Illuccix. This clinically important prostate cancer imaging modality is currently recommended in international clinical practice guidelines including European Association of Urology (EAU) and European Society for Medical Oncology (ESMO),” said Kevin Richardson, CEO of Telix Precision Medicine, in the news release.¹

The European approval of Illuccix adds on to prior approvals in the US, Australia, and Canada.

Prior approvals of the PET imaging agent, including its FDA approval in March 2022, have been supported by findings from the phase 3 VISION trial(NCT03511664). In this study, Illuccix was utilized to help identify patients appropriate for treatment with ¹⁷⁷Lu-PSMA-617.²

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) vs standard of care alone in patients with PSMA-positive mCRPC. 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. Illuccix receives European approval. News release. Telix Pharamaceuticals Limted. January 16, 2025. Accessed January 17, 2025. https://telixpharma.com/news-views/illuccix-receives-european-approval/

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