PSMA-PET imaging product, Gozellix, launches on US market

Gozellix (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection), a prostate-specific membrane antigen (PSMA)-PET imaging agent for prostate cancer, is now commercially available in the US, Telix announced in a news release.¹

Gozellix builds on Telix’s existing imaging portfolio.

Gozellix was approved by the FDA in March 2025.² The agent, after radiolabeling with ⁶⁸Ga, is indicated for PET scanning of PSMA positive lesions in patients with prostate cancer who have suspected metastases and are candidates for initial definitive therapy and patients who have suspected recurrence of prostate cancer based on an elevated serum prostate-specific antigen (PSA) level.

“We are pleased that Gozellix, our next-generation prostate cancer imaging product, is now available coast-to-coast across the United States,” said Kevin Richardson, CEO, Precision Medicine, Telix, in the news release.¹ “Telix is committed to innovation in PSMA imaging, and Gozellix is a result of this focus. It delivers a new level of flexibility in distribution, production, and scheduling, along with the high standard of service and reliability that customers have come to expect from Telix.”

Gozellix has a longer shelf life of up to 6 hours and provides an extended distribution profile compared with previously approved gallium-68 (⁶⁸Ga) PSMA-PET imaging agents, the company noted.

The agent has also shown a 90% specificity in detecting metastases at initial staging. According to Telix, “This clinical performance enables detection of millimeter-scale micrometastases, at PSA levels as low as 0.02 ng/mL.”

The imaging product can be either centrally produced with a cyclotron or locally prepared with a gallium generation with up to 500 mCi of activity. In cyclotron-based production, Gozellix is supported by the ARTMS QUANTM Irradiation System.

The availability of Gozellix builds on Telix’s existing imaging portfolio.

In December 2021, the company received FDA approval for Illuccix, a kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and for patients with suspected recurrence based on elevated serum PSA levels.³ An expanded indication of Illuccix was approved in March 2023 to include patients with metastatic prostate cancer who are indicated for PSMA-directed radioligand therapy (¹⁷⁷Lu-PSMA-617).⁴ Illuccix has also received approvals in Canada and Australia.

According to Telix, Gozellix “will be available alongside the first-generation product, providing choice for customers and patients based on their individual needs.”²

Data on gallium Ga-68 gozetotide

The safety and efficacy of gallium Ga-68 gozetotide were established in the pivotal PSMA-PreRP trial (NCT02919111) and the pivotal PSMA BCR trial (NCT02918357), in the initial definitive therapy and biochemical recurrence settings, respectively.⁵ A total of 960 patients were enrolled across both studies. Each patient received 1 dose of gallium Ga-68 gozetotide.

According to Telix, "The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%."²

Specifically, the PSMA-PreRP trial enrolled 325 patients with intermediate- or high-risk prostate cancer who were considered candidates for prostatectomy and pelvic lymph node dissection.

In the detection of pelvic lymph node metastasis, ⁶⁸Ga-PSMA-11 demonstrated a specificity of 90% (95% CI, 84% to 96%) and a sensitivity of 47% (95% CI, 29% to 65%). The positive predictive value and negative predictive value were 61% (95% CI, 41% to 81%) and 84% (95% CI, 79% to 91%), respectively.

The PSMA-BCR trial enrolled 635 patients with biochemical recurrence of prostate cancer following definitive therapy. Data showed high correct localization rates (CLRs; true positive among all positive PET scans) across all PSA levels assessed. Specifically, the CLR was 92% in PSA levels below 0.5 ng/mL, 83% in PSAs between 0.5 ng/mL and 1 ng/mL, 97% in PSA levels between 1 ng/mL and 2 ng/mL, and 91% in PSAs of 2 ng/mL or higher.

Overall, 91% (95% CI, 85%-95%) of evaluable patients were found to be a true positive in 1 or more regions compared with the composite reference standard. Additionally, 74% of patients had at least 1 positive region detected on ⁶⁸Ga-PSMA-11 PET majority read.

REFERENCES

1. Telix launches new prostate cancer imaging agent, Gozellix, in U.S. News release. Telix Pharmaceuticals. Published online and accessed June 11, 2025. https://www.globenewswire.com/news-release/2025/06/11/3097430/0/en/Telix-Launches-New-Prostate-Cancer-Imaging-Agent-Gozellix-in-U-S.html

2. FDA approves new prostate cancer imaging agent Gozellix. News release. Telix Pharmaceuticals. March 20, 2025. Accessed June 11, 2025. https://telixpharma.com/news-views/fda-approves-new-prostate-cancer-imaging-agent-gozellix/

3. 3. FDA approves Telix’s prostate cancer imaging product, Illuccix. News release. December 20, 2021. Accessed June 11, 2025. https://telixpharma.com/news-views/fda-approves-telixs-prostate-cancer-imaging-product-illuccix/

4. FDA approves expanded indication for Telix’s Illuccix to include patient selection for PSMA-directed radioligand therapy. News release. March 16, 2023. Accessed June 11, 2025. https://telixpharma.com/news-views/fda-approves-expanded-indication-for-telixs-illuccix-to-include-patient-selection-for-psma-directed-radioligand-therapy/

5. Indications and usage. Accessed June 11, 2025. https://illuccixhcp.com/efficacy/