Telix says new kidney cancer imaging agent alters treatment plans for 50% of patients
Telix Pharmaceuticals has shared positive trial data relative to its investigational PET/CT imaging agent for indeterminate renal masses.
The Australia-based biopharmaceutical company announced the positive findings on Wednesday, citing the potential for TLX250-CDx (marketed as Zircaix) to help providers more effectively manage patients’ treatment. Zircaix is indicated for the diagnosis and characterization of clear cell renal cell carcinoma (ccRCC).
New data suggest use of the agent in nearly half of the patients scanned as part of the ZIRCON-X study would have resulted in a change in clinical management compared to standard-of-care imaging exams. What’s more, nearly 20% of patients could have avoided a biopsy if the agent had been used in lieu of routine contrast-enhanced imaging. And an additional 30% would have had their treatment either escalated or de-escalated based on the enhanced visualization afforded by the agent. The data indicate TLX250-CDx provides greater clarity on spatial localization of ccRCC within the kidney, which helps inform providers on the most appropriate treatment route.
“These are compelling results, which demonstrate that TLX250-CDx PET/CT has significant potential to impact clinical decision-making in the diagnostic work-up of patients presenting with small IRMs and give physicians greater confidence in clinical planning,” said Professor Karolien Goffin, MD, a principal investigator on the ZIRCON and ZIRCON-X studies.
“This analysis is another demonstration of the potential clinical usefulness of TLX250-CDx, Telix’s breakthrough precision diagnostic candidate, which has recently been added to international guidelines for renal imaging,” added David N. Cade, MD, group chief medical officer at Telix. “These results indicate that TLX250-CDx may deliver on an unmet need for better noninvasive diagnostic work-up for ccRCC that can improve risk stratification and minimize overtreatment and undertreatment.”
The positive findings come after the U.S. Food and Drug Administration previously shared concerns related to sterility assurance issues during the drug’s production, which resulted in the agency initially denying its approval. In August, Telix said that the issues were “readily addressable” and would begin developing solutions immediately. The agent previously earned the FDA’s Breakthrough Therapy designation and Priority Review status.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.