Telix Pharmaceuticals has dosed the first patient in a US expanded access programme (EAP) for kidney cancer imaging agent, TLX250-CDx (⁸⁹Zr-DFO-girentuximab).
The first patient received the dose at ARA Diagnostic Imaging at Austin Radiological Association in Texas.
This development follows the US Food and Drug Administration (FDA) agreement for an EAP upon successful completion of Telix’s global Phase III Zirconium in Renal Cancer Oncology (ZIRCON) study. This study revealed positive data last year, meeting all co-primary and secondary goals.
TLX250-CDx is Telix’s first-in-class, non-invasive investigational positron emission tomography (PET) imaging agent intended for clear cell renal cell carcinoma (ccRCC).
ARA Diagnostic Imaging molecular radiologist and nuclear medicine specialist and EAP principal investigator Dr John Leahy said: “With TLX250-CDx, for the first time, urologists and urologic oncologists may have a non-invasive way to determine the presence of ccRCC, the most common and aggressive form of kidney cancer.
“We are therefore extremely pleased to have been selected as the inaugural site for this national EAP, with patients in Austin and the surrounding area now able to benefit from greater confidence in their kidney cancer diagnosis and treatment planning.”
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Telix is planning to submit a biologics licence application (BLA) with the FDA for TLX250-CDx, along with other equivalent applications with regulatory agencies.
Telix global medical affairs senior vice-president Mary Jessel said: “Ahead of regulatory approval, this EAP provides continued access to TLX250-CDx to address a clear unmet patient need.
“ZIRCON results demonstrate that TLX250-CDx has the potential to become a new standard of care in the diagnosis and staging of ccRCC, where existing imaging can be inconclusive.”
Recently, Telix dosed the first subject in a European patient (early access) programme for TLX250-CDx.