FDA Approves TLX007-CDx for Prostate Cancer Imaging

TLX007-CDx will have a longer shelf life and wider distribution radius than other formulations of ⁶⁸Ga gozetotide.

The FDA approved TLX007-CDx, a kit for preparing gallium-68 (⁶⁸Ga) gozetotide injection (Gozellix), for PSMA-PET scanning of PSMA-positive lesions in men with prostate cancer who are suspected of having metastasis and are candidates for initial definitive therapy, as well as those with suspected recurrence due to elevated serum prostate-specific antigen (PSA) levels.¹

The novel TLX007-CDx will have a longer shelf life and wider distribution radius than previous ⁶⁸Ga gozetotide injections.¹

“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,” Kevin Richardson, CEO of Telix Precision Medicine, said in the news release. “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.”

Approval for TLX007-CDx is based on data from the prospective, open-label studies PSMA-PreRP (NCT03368547 and NCT02919111) and PSMA-BCR (NCT02940262 and NCT02918357), which confirmed the safety and efficacy of another formulation of ⁶⁸Ga gozetotide.^1,2

Safety

Changes in the uptake of ⁶⁸Ga gozetotide may occur with the use of androgen deprivation therapy (ADT) or other agents targeting the androgen receptor pathway, including androgen receptor antagonists. The effects of these therapies on TLX007-CDx have not been established.^1,2

In both PSMA-PreRP and PSMA-BCR studies, 960 patients were given a dose of TLX007-CDx, with a mean dosage of 188.7 ± 40.7 MBq. The most frequent adverse effects (AEs), occurring at a rate of less than 1%, were dizziness, nausea, and diarrhea.^1,2

Ascorbic acid stabilizer (Ampule), a part of the TLX007-CDx kit, contains sodium metabisulfite, which may cause reactions including life-threatening or less severe anaphylactic symptoms and asthma attacks in patients with a hypersensitivity to the sulfite.^1,2

PSMA-PreRP and PSMA-BCR

The use of TLX007-CDx in patients with suspected metastasis who are candidates for is based on results from the PSMA-PreRP study. Data showed a predictive positive value for PET detection of pelvic lymph node metastasis of 61% (95% CI, 41%-81%).²

The PSMA-BCR, which established the use of TLX007-CDx in men with suspected recurrence of prostate cancer, saw a 340 of 635 patients (54%) correctly detected as true PET-positive (95% CI, 50%-57%).²

Reference

1. FDA approves new prostate cancer imaging agent Gozellix. News release. Telix Pharmaceuticals. Published online March 21, 2025. Accessed March 21, 2025. https://www.globenewswire.com/news-release/2025/03/21/3046974/0/en/FDA-Approves-New-Prostate-Cancer-Imaging-Agent-Gozellix.html
2. Gozellix. Prescribing information. Telix Pharmaceuticals. 2025. Accessed March 21, 2025. https://telixpharma.com/wp-content/uploads/2025/03/Gozellix-prescribing-information.pdf