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The Food and Drug Administration (FDA) in America has accepted the Biologics License Application (BLA) for the breakthrough investigational kidney cancer PET imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for Priority Review. It is expected that TLX250-CDx will be available in the US in 2025.
Girentuximab is an antibody that attaches to an enzyme called carbonic anhydrase IX (CAIX). This enzyme is found in clear cell kidney cancer tumours. 89Zr-DFO-girentuximab (TLX250-CDx) is made from combining a weakly radioactive molecule called zirconium Zr 89 with girentuximab. When given to humans, 89Zr-DFO-girentuximab binds to carbonic anhydrase IX in kidney cancer tumours and can help to tell the difference between kidney cancer, normal tissue, and other tumours.
The Biologics License Application is based on findings from the phase 3 ZIRCON trial looking at TLX250-CDx (89Zr-DFO-girentuximab) in patients with a mass in their kidney that is suspected to be clear cell kidney cancer. The average sensitivity of TLX250-CDx was 86%, and the average accuracy was 87% for the detection of clear cell kidney cancer tumours. Positive predictive values for kidney cancer were more than 90%, including for small and difficult to detect kidney masses. These results were similar for small renal masses.
Overall, the trial reported high accuracy of TLX250-CDx in detecting and characterising clear cell kidney cancer in patients with kidney masses.
Kevin Richardson, Chief Executive Officer, from the company that developed TLX250-CDx said, “We are delighted that the FDA has accepted this BLA as it moves us one step closer to bringing our breakthrough product to patients. We are aiming to revolutionise the management of kidney cancer, just as PSMA-PET/CT scanning has changed the management of prostate cancer. By providing a more definitive clinical diagnosis for renal masses, we believe that TLX250-CDx will help physicians make more timely and confident patient management decisions and more quickly provide patients with a clear understanding of their disease and treatment options……….we are preparing to bring this powerful precision medicine product to market in 2025.”
Currently, TLX250-CDx is available through an expanded access programme in the United States, named patient programmes in Europe, and a special access scheme in Australia for patients outside of clinical trials for whom there is no comparable or satisfactory alternatives. If approved, TLX250-CDx would be the first targeted PET agent specifically for kidney cancer.
