Australian company Telix Pharmaceuticals has submitted a biologics licence application (BLA) to the FDA for its investigational positron emission tomography (PET) imaging agent, Zircaix (TLX250-CDx).  

Zircaix is a radioactive imaging agent intended for the PET/computed tomography (CT) imaging of clear cell renal cell carcinoma (ccRCC). It is designed to visualise tumours by binding to carbonic anhydrase 9 (CAIX), which is over-expressed in ccRCC. It is also intended for imaging of bladder cancer and metastatic triple-negative breast cancer patients. 

The submission is based on positive results from the global Phase III ZIRCON study. The prospective, open-label, multi-centre study enrolled 300 subjects and concluded last year, meeting all the primary and secondary endpoints. Telix aims to initiate programmes for patient access outside clinical trials.  

Earlier this month, Telix dosed the first subject in an early access European programme for Zircaix, at Radboud University Medical Centre in Nijmegen, the Netherlands.  

In the announcement accompanying the submission, Telix chief development officer James Stonecypher said: “If approved by the FDA, TLX250-CDx will be the first targeted radiopharmaceutical imaging agent for kidney cancer to be commercially available to patients in the US. 

“The collaborative approach shown by the FDA under the Breakthrough Therapy designation has been highly valuable as we work to bring this novel, non-invasive, first-in-class 89-zirconium-labeled monoclonal antibody (mAb) based imaging agent to market.” 

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In December 2021, the FDA approved Telix’s lead marketed product, Illucix (TLX591-CDx), a radiopharmaceutical imaging agent that is indicated for PET of prostate-specific membrane antigen (PSMA) in prostate cancer patients. The company signed a deal with Danish company Wiik Pharma to distribute Ilucix across Denmark, Finland, Norway and Sweden last month. 

Last month, Telix teamed up with Mauna Kea to expand the Imaging and Robotics in Surgery (IRiS) Alliance, investing €6m ($6.4m) to develop hybrid pharmaceutical-device products, after initially joining forces in December 2020, to develop advanced image-guided surgical technologies in the field of urologic oncology.