Scienza e Tecnologia
FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
The BLA is based on Telix's successful global Phase 3 ZIRCON study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions . The results of this study were published in in September 2024 , in a peer-reviewed manuscript by Professor Brian Shuch ( University of California, Los Angeles , UCLA ) and colleagues . The paper outlines the critical unmet need for a new, non-invasive technique that can accurately detect and differentiate ccRCC from other renal masses in patients and concluded that TLX250-CDx meets this need and 'has the potential to be practice changing.'
Kevin Richardson , Chief Executive Officer, Precision Medicine, said, "We are delighted that the FDA has accepted this BLA as it moves us one step closer to bringing our breakthrough product to patients. We are aiming to revolutionize the management of kidney cancer, just as PSMA-PET/CT scanning has changed the management of prostate cancer. By providing a more definitive clinical diagnosis for renal masses, we believe that Zircaix will help physicians make more timely and confident patient management decisions and more quickly provide patients with a clear understanding of their disease and treatment options. Building further on Telix's successful urology franchise, we are preparing to bring this powerful precision medicine product to market in 2025 ."
TLX250-CDx (Zircaix® ) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix's pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers . Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation.
As part of Telix's commitment to access to medicine, the Company operates 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. TLX250-CDx has not received a marketing authorization in any jurisdiction and is for investigational use only.
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia , with international operations in the United States , Canada , 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
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] Prescription Drug User Fee Act.
[4] Z irconium i n R enal C ancer On cology, ClinicalTrials.gov ID: NCT03849118.
[5] Telix ASX disclosures 7 November 2022 .
[6] Shuch et al. 2024.
[7] Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography.
[8] Subject to regulatory approval.
[9] ClinicalTrials.gov ID: NCT06090331.
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