FDA Approves PET Imaging Agent for Prostate Cancer

The new drug application for TLX007-CDx has been approved by the FDA for patients with prostate cancer.

The PET imaging agent, TXL007-CDx, a kit for the preparation of gallium-68 gozetotide (⁶⁸Ga) injection for patients with prostate cancer has been approved by the FDA, according to a press release from Telix.¹

TLX007-CDx is indicated for PET scanning of prostate-specific membrane antigen (PSMA) after radiolabeling ⁶⁸Ga for patients with prostate cancer who have suspected metastasis and may be candidates for definitive therapy. Additionally, patients may receive this treatment if there is suspicion of recurrence based on the elevated serum prostate-specific antigen level.

“Securing FDA approval for [TLX007-CDx] is a major win for patients with prostate cancer, who gain enhanced access to state-of-the-art ⁶⁸Ga PSMA-PET imaging. Telix continues to invest in innovation across our portfolio, and [TLX007-CDx] is a testament to this continuous improvement approach. With the launch of [TLX007-CDx], 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,” Kevin Richardson, chief executive officer of Telix Precision Medicine, said in the press release.¹

The approval is based on results from the PSMA-PreRP trial (NCT03368547 and NCT02919111) and the PSMA-BCR trial (NCT02940262 and NCT02918357).² Of note, the trials evaluated different formulations of ⁶⁸Ga gozetotide.

References

1. FDA approves new prostate cancer imaging agent Gozellix. News release. Telix. March 20, 2025. Accessed March 20, 2025. https://tinyurl.com/kexv2u7e
2. Gozellix. Prescribing Information. Telix. March 2025. Accessed March 20, 2025. https://tinyurl.com/3ekajmp9