Telix Submits Biologics License Application (BLA) for TLX250-CDx (ZircaixTM) for Imaging of Kidney Cancer

Melbourne (Australia) and Indianapolis (IN, U.S.) – 19 December 2023. Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (ZircaixTM, 89Zr- DFO-girentuximab) 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.

Dr. Christian Behrenbruch, Managing Director and Telix Group CEO 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, 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.”

This submission is based on Telix’s successful global Phase III ZIRCON study (Zirconium in Renal Cancer Oncology, ClinicalTrials.gov ID: NCT03849118), which reported positive results in November 2022, meeting all co-primary and secondary endpoints.

Telix has opened an expanded access program in the U.S. and a named patient program in Europe to allow access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options. 

Small clarification that TLX250 was in the EAP since July 2022

https://appliedradiology.com/articles/last-patient-dosed-in-telix-s-phase-iii-zircon-study

And Telix finally got their first patient in the EAP for TLX250 in December 2023 as seen in the news.

That's a big time interval to get things ready for the EAP. Have to find out what caused this.