Telix Pharmaceuticals has dosed the first subject in a European named patient (early access) programme for kidney cancer imaging agent, TLX250-CDx (⁸⁹Zr-DFO-girentuximab).
The programme in the Netherlands is evaluating the investigational positron emission tomography (PET) imaging agent for clear cell renal cell carcinoma (ccRCC), which is a common form of kidney cancer.
The first patient received the dose at Radboud University Medical Centre in Nijmegen, the Netherlands.
Through this programme, doctors may seek personal access to TLX250-CDx to utilise it in PET imaging for characterising renal masses in cases of ccRCC.
It comes after Telix concluded its international Phase III ZIRCON study, which achieved positive results in November 2022, meeting all primary and secondary goals.
Telix Europe, Middle East and Africa (EMEA) region medical director Frédéric Fantino said: “The first patient dosed in this European named patient programme is a significant step for Telix to support continued unmet patient need and educate key opinion leaders on the potential of TLX250-CDx to change the standard of care in the diagnosis and management of ccRCC.
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“The ZIRCON study has shown this imaging agent to be highly sensitive and specific in the detection of ccRCC, where existing imaging techniques are sometimes inconclusive.”
Telix is moving forward to submit a biologics licence application (BLA) for the imaging agent to the US Food and Drug Administration (FDA) and equivalent applications with regulatory agencies in major commercial jurisdictions.
In August 2023, Telix dosed the first Chinese patient in the pivotal Phase III registration trial of TLX591-CDx (Illuccix), a kit designed to prepare 68Ga-PSMA-11 for PET imaging of prostate cancer.
The Phase III open-label, single-arm, prospective multicenter Illuccix China study is designed to be carried out in patients with biochemically recurrent (BCR) prostate cancer.
