Telix Pharmaceuticals Reports the US FDA’s BLA Acceptance with Priority Review of Zircaix (89Zr-DFO-girentuximab) for Kidney Cancer Imaging
Shots:
- The US FDA has accepted BLA & granted Priority Review to Zircaix (TLX250-CDx) for the detection of clear cell renal cell cancer (ccRCC) in pts (PDUFA: 27 Aug 2025). Expected to launch in 2025
- BLA was based on P-III (ZIRCON) study assessing sensitivity & specificity of 89Zr-TLX250 in adult pts (n=300), where 284 evaluable pts met 1 & 2EPs of 86% sensitivity, 87% specificity & 93% PPV for ccRCC incl. tough-to-detect lesions. Data is published in The Lancet
- Zircaix binds to carbonic anhydrase IX (CAIX) on ccRCC cells to produce high tumor-to-background imaging contrast with strong intra & inter-reader consistency, providing non-invasive approach for diagnosis & characterization of ccRCC
Ref: PRNewswire | Image: Telix Pharmaceuticals
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