FDA approves PET imaging product Gozellix for prostate cancer

Today, March 20, 2025, the FDA approved Gozellix (TLX007-CDx), a proprietary cold kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection, Telix Pharmaceuticals announced in a news release.¹

Gozelliz has a longer shelf life of up to 6 hours.

Specifically, Gozellix—after radiolabeling with ⁶⁸Ga—is indicated 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.

“Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art ⁶⁸Ga PSMA-PET imaging," said Kevin Richardson, CEO of Telix Precision Medicine, in the news release.¹ "Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach. With the launch of Gozellix, our team is excited to be bringing the new generation of prostate cancer scanning to more American men, delivered with the reliability, service and flexibility that customers have come to expect from Telix.”

According to the company, Gozelliz 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.

Telix added, “The ability to reliably deliver the product much further from its point of production means Gozellix can reach PET cameras that are currently not served by any PSMA imaging providers, bringing the accuracy and clinical utility of gallium-based imaging to more patients across the U.S.” The company believes that this design will further expand the availability, distribution, and scheduling flexibility of PSMA-PET imaging.

“The scheduling flexibility and accessibility, along with the excellent clinical performance of ⁶⁸Ga-based PSMA-PET imaging, has enabled Telix to drive rapid geographic expansion of PSMA-PET imaging with our first product Illuccix,” explained Dr Christian Behrenbruch, managing director and Group CEO of Telix, in a prior news release.² “A core value of our company is the commitment to improving access to medicine and delivering clinical utility that will benefit patients, very much reflected in the development of this exciting new product. We believe this is particularly important as demand for PSMA-PET imaging is forecast to grow significantly over the coming decade.”

Additionally, Telix believes that Gozellix may be eligible for full reimbursement, with reduced or no patient co-insurance, which would expand access to more patients.

The approval of Gozelliz builds on Telix’s exisiting 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.⁴ 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).^5 68Ga-PSMA-11 has also received approvals in Canada and Australia.

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

Data on gallium Ga-68 gozetotide

The safety and efficacy of gallium Ga-68 gozetotide were established in the PSMA-PreRP trial (NCT02919111 and NCT02611882) and the PSMA BCR trial (NCT02918357), in the initial definitive therapy and biochemical recurrence settings, respectively. 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%."¹

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.⁵ Intermediate- or high-rsik disease was defined as having at least 1 of the following: a PSA level of 10 ng/mL or higher, a T-stage of T2b or higher, or a Gleason score of 6 or higher.

In the detection of pelvic lymph node metastasis, ⁶⁸Ga-PSMA-11 demonstrated a specificity of 90% (95% CI, 84%-96%) and a sensitivity of 47% (95% CI, 29-65%). The positive predictive value and negative predictive value were 61% (95% CI, 41%-81%) and 84% (95% CI, 79%-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. FDA approves new prostate cancer imaging agent Gozellix. News release. Telix Pharmaceuticals. Published online and accessed March 20, 2025. https://telixpharma.com/news-views/fda-approves-new-prostate-cancer-imaging-agent-gozellix/

2. Telix submits NDA for new prostate cancer imaging agent. News release. Telix Pharmaceuticals. May 27, 2024. Accessed March 20, 2025. https://telixpharma.com/news-views/telix-submits-nda-for-new-prostate-cancer-imaging-agent/

3. FDA approves Telix’s prostate cancer imaging product, Illuccix. News release. December 20, 2021. Accessed March 20, 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 March 20, 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 March 20, 2025. https://illuccixhcp.com/efficacy/