Salute e Benessere
Telix Completes TLX250-CDx (Zircaix®) BLA Submission for Kidney Cancer Imaging
As part of the BLA submission process, Telix has requested a Priority Review under the eligibility criteria of the Breakthrough Therapy designation . If granted, this would potentially support an expedited review time. If Zircaix® 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®."
As part of Telix's commitment to access to medicine, the Company has opened an expanded access program (EAP) in the U.S. , 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 eap-americas@telixpharma.com or complete the form here for further information.
Physicians in Europe and Australia who may have eligible patients can email eap-emea@telixpharma.com and eap-apac@telixpharma.com, 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 https://telixpharma.com/our-portfolio/clinical-trials/
TLX250-CDx (Zircaix® ) 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 . 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.
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 ( Ga) gozetotide injection (also known as Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA) , by the Australian Therapeutic Goods Administration (TGA) , and by Health Canada . No other Telix product has received a marketing authorisation in any jurisdiction.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
Legal Notices
[1] Positron emission tomography.
[2] Brand name subject to final regulatory approval.
[3] Telix ASX disclosure 19 December 2023 .
[4] Z irconium i n R enal C ancer On cology, ClinicalTrials.gov ID: NCT03849118.
[5] Telix ASX disclosures 7 November 2022 .
[6] Telix ASX disclosure 1 July 2020 .
[7] ClinicalTrials.gov ID: NCT06090331.
[8] Telix ASX disclosure 20 December 2021 .
[9] Telix ASX disclosure 2 November 2021 .
[10] Telix ASX disclosure 14 October 2022 .
Logo - https://mma.prnewswire.com/media/1920208/TeliMain_Logo_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/telix-completes-tlx250-cdx-zircaix-bla-submission-for-kidney-cancer-imaging-302161370.html