Telix submits application for TLX250-CDx for kidney cancer imaging

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Telix (ASX:TLX) has submitted its Biologics License Application (BLA) to the US FDA for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (Zircaix) in clear cell renal cell carcinoma (ccRCC).

Under the Breakthrough Therapy designation, TLX250-CDx has been granted a rolling review process, which enables a progressive submission and review of required modules in a timetable pre-agreed with the FDA. With the BLA submission, Telix has also requested Priority Review, which, if granted, would support an expedited review time.

Telix Group managing director and CEO Dr Christian Behrenbruch said, “This is a major milestone and achievement for Telix, which paves the way for a commercial availability for patients in the U.S. in 2024, subject to regulatory review and approval.”

James Stonecypher, chief development officer at Telix, added, “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 U.S.. 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.”

Associate Professor Brian Shuch, MD, the director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology, said, “The ZIRCON study demonstrated the superior sensitivity and specificity of this advanced diagnostic imaging agent, which, if approved, will be the first and only agent available to target carbonic anhydrase IX, a highly relevant target in kidney cancer. This delivers on a major unmet need to provide confidence in the diagnosis of ccRCC, the most aggressive and common form of kidney cancer.”

The company said the submission is based on Telix’s successful global Phase 3 ZIRCON study, which reported positive results in November 2022, meeting all co-primary and secondary endpoints.