Noninvasive ccRCC Imaging Agent 89Zr-girentuximab Undergoes Biologics License Application Process

Telix Pharmaceuticals Ltd has announced their submission of a Biologics License Application to the FDA for the investigational drug ⁸⁹Zr-girentuximab to be used in third positron emission tomography (PET³) scans for noninvasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC).

The phase 3 ZIRCON trial demonstrated positive results with use of the agent for patients with ccRCC; it met all primary and secondary endpoints.  In a group of 284 evaluable patients, ⁸⁹Zr-girentuximab had a sensitivity rate of 86% as well as a specificity rate of 87%. A 93% positive-predictive value for ccRCC was also achieved across three independent radiology readers.

⁸⁹Zr-girentuximab provided an accurate and noninvasive method for diagnosing and characterizing ccRCC, with confidence intervals exceeding expectations among all three readers, demonstrating its high accuracy and consistency.

If approved, ⁸⁹Zr-girentuximab will be the first and only targeted PET agent specifically used for detection of kidney cancer to be commercially available in the US.

Telix’s gallium-68 imaging product has previously been approved by the FDA for the preparation of prostate-specific membrane antigen PET imaging of prostate cancer.