Danish Medicines Agency approves PSMA-PET imaging product for prostate cancer

The Danish Medicines Agency (Lægemiddelstyrelsen) has approved Illuccix, a radiopharmaceutical cold kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide (PSMA-11) injection, Telix Pharmaceuticals announced in a news release.¹.

An expanded indication of Illuccix was approved in the US in March 2023.

After radiolabeling with gallium-68, Illuccix is indicated for PET detection of prostate-specific membrane antigen (PSMA)-positive lesions in adult patients with prostate cancer.

Specifically, Illuccix is approved for 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 serum prostate-specific antigen (PSA) levels following primary curative therapy, and for the identification of patients with PSMA-positive progression metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.

"We are delighted that Illuccix has been approved in Denmark with this broad label demonstrative of clinical utility at multiple critical points in the prostate cancer journey,” said Raphaël Ortiz, CEO of Telix International, in the news release.¹ “Danish physicians and their patients will now have access to Telix's innovative gallium-based PSMA-PET imaging agent, along with the efficiencies and scheduling flexibility of generator-produced gallium."

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

Data on Illuccix

Prior approvals of the PET imaging agent, including its initial FDA approval in December 2021, were supported by findings from 2 prospective clinical trials that included a total of 960 men with prostate cancer who each received 1 injection of ⁶⁸Ga PSMA-11.²

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 PET demonstrated a clinically important rate of metastatic cancer confirmed by surgical pathology in patients with positive readings in the pelvic lymph nodes.

The second trial included 635 patients who had rising serum PSA levels after initial prostate surgery or radiotherapy. Of those, 74% had at least 1 positive lesion detected by ⁶⁸Ga PSMA-11 PET in at least 1 body region. In total, 91% of patients with positive ⁶⁸Ga PSMA-11 PET readings who had correlative tissue pathology from biopsies—and 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.

An expanded indication of Illuccix was approved in the US in March 2023, which enabled use of the agent for selection of patients for PSMA-directed therapy. This expansion was supported by data from the phase 3 VISION trial (NCT03511664), in which Illuccix was utilized to help identify patients appropriate for treatment with ¹⁷⁷Lu-PSMA-617 (Pluvicto).³

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).

In total, the international, open-label VISION 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 approved in Denmark. News release. Published online and accessed February 11, 2025. https://www.prnewswire.com/da/pressemeddelelser/illuccix-approved-in-denmark-302373368.html

2. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. News release. US Food & Drug Administration. December 20, 2021. Accessed February 11, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-psma-targeted-pet-imaging-drug-men-prostate-cancer

3. 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