On June 2, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has completed the submission of a Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational radiodiagnostic PET[1] agent, TLX250-CDx (Zircaix[2], 89Zr-DFO-girentuximab), for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC) (Press release, Telix Pharmaceuticals, JUN 2, 2024, View Source [SID1234643944]).

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The rolling BLA submission, initiated in December 2023[3] with timelines pre-agreed with the FDA, was based on Telix’s successful global Phase III ZIRCON[4] study in ccRCC. The clear cell variant of renal cancer is the most common and aggressive sub-type of kidney cancer. The ZIRCON study met all co-primary and secondary endpoints, demonstrating a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in small, difficult to detect lesions[5].

As part of the BLA submission process, Telix has requested a Priority Review under the eligibility criteria of the Breakthrough Therapy designation[6]. If granted, this would potentially support an expedited review time. If Zircaix[2] is approved, TLX250-CDx will be the first targeted radiopharmaceutical imaging agent specifically for kidney cancer to be commercially available in the U.S. and further builds on Telix’s successful urology imaging franchise.

James Stonecypher, Chief Development Officer at Telix, stated, "Completing the BLA submission for TLX250-CDx represents a significant milestone for Telix as we bring our Breakthrough investigational kidney cancer imaging agent closer to market as a non-invasive diagnostic for patients. We believe TLX250-CDx is a natural follow-on product to Illuccix as it is targeted at the same clinical stakeholders, the urologist and urologic oncologist, and leverages the proven commercial and distribution infrastructure developed through the launch of Illuccix."

TLX250-CDx International Expanded Access

As part of Telix’s commitment to access to medicine, the Company has opened an expanded access program (EAP) in the U.S.[7], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options.

U.S. patients, or physicians who may have eligible patients in the U.S., can e-mail [email protected] or complete the form here for further information.

Physicians in Europe and Australia who may have eligible patients can email [email protected] and [email protected], respectively, for further information about TLX250-CDx named patient access.

Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link.

For more information about ongoing clinical trials of TLX250-CDx, please visit View Source

About TLX250-CDx (Zircaix[2])

TLX250-CDx (Zircaix[2]) is a PET diagnostic imaging agent that is under development to characterise indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, was completed in 2022 and met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent readers[5]. We believe this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation.