A biologics license application has been submitted to the FDA for 89Zr-DFO-girentuximab (TLX250-CDx; Zircaix), a novel PET imaging agent for clear cell renal cell carcinoma (ccRCC). This submission is backed by results from the ZIRCON phase 3 trial, which demonstrated the agent’s effectiveness over traditional PET/CT imaging in detecting malignant RCC lesions. Preliminary results showed high sensitivity and specificity rates, underscoring its potential in accurately diagnosing ccRCC.
The FDA previously recognized the promise of 89Zr-DFO-girentuximab, granting it breakthrough therapy designation in 2020. The managing director and chief executive officer of Telix Group, Dr Christian Behrenbruch, is hopeful for its commercial release in the United States by 2024, pending regulatory approval. The ZIRCON trial, a confirmatory, multi-center study, focused on comparing the sensitivity and specificity of this agent with standard PET/CT imaging for detecting ccRCC in patients with indeterminate renal masses. 89Zr-DFO-girentuximab could potentially become the first targeted radiopharmaceutical imaging agent for kidney cancer available in the United States. .
Reference: Seymour C. BLA Submitted to FDA for PET Imaging Agent TLX250-CDx in RCC. OncLive. Updated January 4, 2024. Accessed February 2, 2024. https://www.onclive.com/view/bla-submitted-to-fda-for-pet-imaging-agent-tlx250-cdx-in-rcc
Link: https://www.onclive.com/view/bla-submitted-to-fda-for-pet-imaging-agent-tlx250-cdx-in-rcc
