Telix Pharmaceuticals is highlighting positive clinical results from a study that has tested its investigational kidney cancer PET imaging agent, TLX250-CDx.
The phase III Zirconium in Renal Cancer Oncology (ZIRCON) study included 284 patients. It found that the agent had an 86% sensitivity and 87% specificity for detecting the cell phenotype and diagnosing the presence and spread of clear cell renal cell carcinoma (ccRCC). The study also showed that the agent can detect disease in tumors less than 4 cm at 85% sensitivity and 89% specificity.
In July 2020, the company received breakthrough designation for the agent from the U.S. Food and Drug Administration (FDA).
