TLX250-CDx (Zircaix) is the company’s investigational radiodiagnostic PET agent for the renal masses characterisation as ccRCC or non-ccRCC in a non-invasive manner.
Initiated in December 2023, the rolling BLA submission follows the success of the global Phase III ZIRCON study in ccRCC.
The ZIRCON study achieved all primary and secondary endpoints, recording 86% sensitivity, 87% specificity, and a 93% positive predictive value for ccRCC, including those small lesions that are typically challenging to identify.
Telix is also seeking priority review from the FDA, which could be granted under the Breakthrough Therapy designation criteria.
Additionally, Telix is facilitating patient access to TLX250-CDx through various programmes outside of clinical trials.
These include an expanded access programme in the US, named patient programmes in Europe, and a special access scheme in Australia, catering to patients with no other satisfactory treatment options.
Telix chief development officer James Stonecypher said: “Completing the BLA submission for TLX250-CDx represents a significant milestone for Telix as we bring our Breakthrough investigational kidney cancer imaging agent closer to market as a non-invasive diagnostic for patients.
“We believe TLX250-CDx is a natural follow-on product to Illuccix as it is targeted at the same clinical stakeholders, the urologist and urologic oncologist, and leverages the proven commercial and distribution infrastructure developed through the launch of Illuccix.”