Norway Grants Marketing Authorization to Illuccix PSMA-PET Imaging Agent in Prostate Cancer

The Norwegian Medical Products Agency (NOMA) has granted marketing authorization to the prostate cancer PET imaging agent gallium-68 (68Ga) gozetotide injection (68Ga PSMA-11; TLX591-CDx; Illuccix) for the detection and localization of prostate-specific membrane antigen (PSMA)–positive lesions in adults with prostate cancer.1

The kit, which is used for the preparation of 68Ga PSMA-11, is indicated for primary staging of patients with high-risk prostate cancer prior to primary curative therapy; suspected recurrent prostate cancer in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy; and identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.

“The approval of Illuccix in Norway will enable a clinically validated PSMA-PET product to be more widely available, allowing health care providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces Telix’s ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe,” Raphaël Ortiz, chief executive officer of Telix International, stated in a news release.

The approval is grounded in part by data from the international phase 3 VISION trial (NCT03511664) in which patients with mCRPC who had previously been treated with an androgen receptor pathway inhibitor (ARPI) and 1 to 2 taxane regimens and who had PSMA-positive 68Ga-PSMA-PET/CT scans experienced an improvement in radiographic progression-free survival (rPFS) and overall survival (OS) with lutetium Lu 177 vipivotide tetraxetan (Pluvicto; formerly 177Lu-PSMA-617) vs standard of care therapy.2

At a median follow-up of 20.9 months, the median rPFS was 8.7 months in the investigational arm vs 3.4 months in the control arm (HR, 0.40; 99.2% CI, 0.29-0.57; P <.001). Median OS was 15.3 months and 11.3 months in the investigational and control arms, respectively (HR, 0.62; 95% CI, 0.52-0.74; P <.001).

In December 2022, the European Commission approved lutetium Lu 177 vipivotide tetraxetan for use in combination with androgen deprivation therapy with or without an ARPI for patients with PSMA-positive mCRPC in accordance with data from the VISION trial.3

Subsequently reported data from a US expanded access program (NCT04825652) indicated that treatment with lutetium Lu 177 vipivotide tetraxetan elicited similar efficacy and safety results to those reported in the pivotal trial.4

The program enrolled patients at 4 institutions in the United States with available toxicity and outcome data including OS and a PSA response rate of at least 50% (PSA50). Differences in baseline characteristics, outcome data, and toxicity between the expanded access and VISION trial populations were assessed using T testing of proportions and survival analyses.

A total of 117 patients with mCRPC who had received lutetium Lu 177 vipivotide tetraxetan as part of the expanded access program between May 2021 and March 2022 were included in the analysis. These patients were more heavily pretreated with AR signaling inhibitors (ARSIs) than those in the VISION trial (≥2 ARSI regimens: 70% vs 46%; P <.001) and had worse ECOG performance status at baseline (ECOG score ≥ 2: 19% vs 7%; P <.001).

The median OS was 15.1 months in the expanded access cohort vs 15.3 months in the VISION cohort (P >.05). Additionally, the PSA50 response rates were similar between the two populations, at 42% in the expanded access population vs 46% in the VISION trial population (P =.50).

With respect to safety, patients in both populations had similar rates of grade 3 or higher anemia (expanded access, 18%; VISION, 13%, respectively; P =.15), thrombocytopenia (13%; 8%; P =.13), and neutropenia (3%; 3%; P =.85).

References

1. Illuccix approved in in Norway. News release. Telix Pharmaceuticals. February 24, 2025. Accessed March 5, 2025. https://telixpharma.com/news-views/illuccix-approved-in-norway/#:~:text=Illuccix%2C%20after%20radiolabelling%20with%20gallium,prior%20to%20primary%20curative%20therapy
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. 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 March 5, 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
4. Murthy V, Voter AF, Nguyen K, et al. Efficacy and toxicity of [177Lu]Lu-PSMA-617 for metastatic castration-resistant prostate cancer: results from the U.S. expanded-access program and comparisons with phase 3 VISION data. J Nucl Med. 2024;65(11):1740-1744. doi:10.2967/jnumed.124.267816.