The programme is evaluating an investigational PET imaging agent for clear cell renal cell carcinoma. Credit: Magic mine/Shutterstock.com.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.