Kelly Stratton, MD, reacts to FDA approval of Gozellix for prostate cancer imaging

The FDA approved Gozellix (TLX007-CDx), a proprietary cold kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection, in March 2025. In a recent interview with Urology Times®, Kelly L. Stratton, MD, FACS, offers his thoughts on how this approval will impact the clinical workflow of PSMA-PET imaging.

According to Stratton, “The approval of Gozellix is likely to both streamline and expand access to PSMA-PET imaging, hopefully broadening the distribution and use of gallium 68.”

According to Telix, the developer of the agent, 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. Stratton touched on these benefits, explaining that the simplistic preparation and extended shelf life of Gozellix should enable better integration into clinical workflows, easier scheduling, and expanded access to sites that lack on-site radiopharmaceutical capabilities.

Stratton is an assistant professor of urologic oncology and an adjunct associate professor of medicine at the University of Oklahoma (OU) College of Medicine and the chair of urologic oncology at the OU Stephenson Cancer Center in Oklahoma City.

Expanding on the advantages of an extended shelf life, Stratton said, “This is especially important for sites that are in, for instance, rural areas or centers that don't have their own radiopharmaceutical pharmacy, and so they rely on deliveries from regional hubs.”

The hope, he says, is to expand access to PSMA-PET to patients in underserved populations, such as those in rural settings or veterans.

REFERENCE

1. FDA approves new prostate cancer imaging agent Gozellix. News release. Telix Pharmaceuticals. March 20, 2025. Accessed April 8, 2025. https://telixpharma.com/news-views/fda-approves-new-prostate-cancer-imaging-agent-gozellix/