MELBOURNE, Australia, Feb. 26,
2025 /PRNewswire/ -- Telix Pharmaceuticals
Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces
that the United States (U.S.) Food
and Drug Administration (FDA) has accepted the Biologics License
Application (BLA) for its breakthrough investigational kidney
cancer PET[1] imaging agent TLX250-CDx
(Zircaix®[2], 89Zr-DFO-girentuximab),
granted a Priority Review and provided a PDUFA[3] date
of 27 August 2025, paving the way for
a U.S. commercial launch in 2025.
If approved, TLX250-CDx will become the first commercially
available imaging agent to accurately and non-invasively diagnose
and characterize clear cell renal cell carcinoma (ccRCC), the most
common and one of the most aggressive sub-types of kidney cancer.
It works by specifically binding to carbonic anhydrase IX (CAIX), a
validated target protein expressed on 95% of ccRCC cells to produce
images with high tumor-to-background ratio and high intra- and
inter-reader consistency.
The BLA is based on Telix's successful global Phase 3
ZIRCON[4] 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[5]. The results of this study were
published in The Lancet Oncology in September 2024, in a peer-reviewed manuscript by
Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues[6]. 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[7] scanning has changed the management of
prostate cancer. By providing a more definitive clinical diagnosis
for renal masses, we believe that Zircaix[2] 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[8]."
About TLX250-CDx
TLX250-CDx (Zircaix®[2]) 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[5]. 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.[9], 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.
About Telix Pharmaceuticals Limited
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.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the
Telix Pharmaceuticals Limited Disclosure Committee on behalf of the
Board.
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Accordingly, you should not place undue reliance on these
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©2025 Telix Pharmaceuticals Limited. Telix
Pharmaceuticals®, Telix Group company, and Telix
product names and logos are trademarks of Telix Pharmaceuticals
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[1] Positron emission tomography.
[2] Brand name subject to final regulatory approval.
[3] Prescription Drug User Fee Act.
[4] Zirconium in Renal Cancer Oncology,
ClinicalTrials.gov ID: NCT03849118.
[5] Telix ASX disclosures 7 November
2022.
[6] Shuch et al. Lancet Oncology. 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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