Telix Completes TLX250-CDx (Zircaix™) BLA Submission for Kidney Cancer Imaging
MELBOURNE, Australia, June 03, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces 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 PET1 agent, TLX250-CDx (Zircaix™2, 89Zr-DFO-girentuximab), for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC).
The rolling BLA submission, initiated in December 20233 with timelines pre-agreed with the FDA, was based on Telix’s successful global Phase III ZIRCON4 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 lesions5.
As part of the BLA submission process, Telix has requested a Priority Review under the eligibility criteria of the Breakthrough Therapy designation6. 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 or complete the form for further information.
Physicians in Europe and Australia who may have eligible patients can email and , 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 .
For more information about ongoing clinical trials of TLX250-CDx, please visit
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: ) 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 readers6. 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.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).
Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)8, by the Australian Therapeutic Goods Administration (TGA) 9, and by Health Canada10. No other Telix product has received a marketing authorisation in any jurisdiction.
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Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email:
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Zircaix™2 names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
1 Positron emission tomography.
2 Brand name subject to final regulatory approval.
3 Telix ASX disclosure 19 December 2023.
4 Zirconium in Renal Cancer Oncology, ClinicalTrials.gov ID: .
5 Telix ASX disclosures 7 November 2022.
6 Telix ASX disclosure 1 July 2020.
7 ClinicalTrials.gov ID: .
8 Telix ASX disclosure 20 December 2021.
9 Telix ASX disclosure 2 November 2021.
10 Telix ASX disclosure 14 October 2022.
