Illuccix PSMA-PET Imaging Kit Earns Czech Marketing Authorization in Prostate Cancer

Illuccix PSMA-PET Imaging in Prostate Cancer |

Image Credit: © Sebastian Kaulitzki – stock.adobe.com

The PET imaging agent gallium-68 (68Ga) gozetotide injection (68Ga PSMA-11; TLX591-CDx; Illuccix) has received marketing authorization by the Czech Republic’s State Institute for Drug Control for the detection and localization of prostate-specific membrane antigen (PSMA)–positive lesions in adult patients with prostate cancer.1

Following 68Ga radiolabeling, the agent is now indicated in the Czech Republic for PSMA-positive lesion detection with PET in adult patients with prostate cancer in the following settings: primary staging of patients with high-risk prostate cancer before primary curative treatment; suspected recurrent prostate cancer in patients with increasing levels of serum prostate-specific antigen following curative therapy; and identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (CRPC) for whom PSMA-directed therapy is indicated.

“Waiting for a diagnosis can be a difficult time for men with suspected prostate cancer. In this regard, PSMA-PET imaging has transformed how we assess the disease, offering greater accuracy and confidence in determining its stage, and guiding the correct course of action,” David Zogala, PhD, president of the Czech Society of Nuclear Medicine, stated in a news release. “The approval of Illuccix will increase access to advanced imaging in the Czech Republic, broadening the portfolio of available PSMA tracers and supporting precise detection and timely decision-making for patients."

Zogala is also the responsible director of the Department of Nuclear Medicine at the General University Hospital Prague and an assistant professor at the Charles University in Prague in the Czech Republic.

The approval is partially supported by findings from the phase 3 VISION trial (NCT03511664), which evaluated the radioligand therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto) vs standard-of-care treatment (SOC) in patients with metastatic CRPC.2 Eligible patients needed to have received prior treatment with an androgen receptor pathway inhibitor (ARPI) and 1 or 2 taxane-based regimens and have PSMA-positive 68Ga-labeled PSMA-11 PET/CT scans. The alternate primary end points were radiographic progression-free survival (rPFS) and overall survival (OS).

At a median follow-up of 20.9 months, patients who received lutetium Lu 177 vipivotide tetraxetan plus SOC therapy (n = 385) achieved a median rPFS of 8.7 months compared with 3.4 months in the SOC alone arm (n = 196; HR, 0.40; 99.2% CI, 0.29-0.57; P < .001). The median OS in the investigational arm was 15.3 months vs 11.3 months in the control arm (HR, 0.62; 95% CI, 0.52-0.74; P < .001).

In February 2025, Illuccix received marketing authorization from the Norwegian Medical Products Agency for the detection and localization of PSMA-positive lesions in adult patients with prostate cancer.3 In December 2022, the European Commission approved lutetium Lu 177 vipivotide tetraxetan in combination with androgen deprivation therapy with or without an ARPI for use in patients with PSMA-positive metastatic CRPC; the approval was based on data from VISION.4

Illuccix will be made available in the Czech Republic via Telix Pharmaceuticals’ distribution partner THP Medical Products.1

“The Czech Republic has been at the forefront of adopting advanced diagnostics, with Czech nuclear medicine specialists playing a leading role in integrating PSMA-PET imaging into clinical practice,” Raphaël Ortiz, chief executive officer of Telix International, added in the news release. “We are pleased to support their efforts by working with THP Medical Products to deliver Illuccix, a clinically validated imaging solution that will help ensure more men benefit from accurate prostate cancer detection and ongoing management.”

References

1. Telix's Illuccix PSMA-PET imaging agent approved in the Czech Republic. News release. Telix Pharmaceuticals. May 5, 2025. Accessed May 9, 2025. https://telixpharma.com/news-views/telixs-illuccix-psma-pet-imaging-agent-approved-in-the-czech-republic/
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
3. Illuccix approved in in Norway. News release. Telix Pharmaceuticals. February 24, 2025. Accessed May 9, 2025. https://telixpharma.com/news-views/illuccix-approved-in-norway/#:~:text=Illuccix%2C%20after%20radiolabelling%20with%20gallium,prior%20to%20primary%20curative%20therapy
4. Novartis receives European Commission approval for Pluvicto as the first targeted radioligand therapy for treatment of progressive PSMA-positive metastatic castration-resistant prostate cancer. News release. Novartis. December 13, 2022. Accessed May 9, 2025. https://www.novartis.com/news/media-releases/novartis-receives-european-commission-approval-pluvicto-first-targeted-radioligand-therapy-treatment-progressive-psma-positive-metastatic-castration-resistant-prostate-cancer