- Telix Pharmaceuticals (ASX:TLX) submits its BLA to the US FDA for its investigational PET imaging agent Zircaix for imaging of kidney cancer
- Zircaix has been granted a rolling review process, which allows for a progressive submission and review of required modules in an agreed-upon timetable with the FDA
- TLX MD and CEO says the submission marks a major milestone for the company
- TLX Chief Development Officer added that if approved, Zircaix would become the first targeted radiopharmaceutical imaging agent for kidney cancer to ever be commercially available to patients in the US
- TLX shares last traded at $9.78
Telix Pharmaceuticals (ASX:TLX) has submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its investigational PET imaging agent Zircaix for imaging of kidney cancer.
Zircaix has been granted a rolling review process, which allows for a progressive submission and review of required modules in an agreed-upon timetable with the FDA.
“This is a major milestone and achievement for Telix, which paves the way for commercial availability for patients in the U.S. in 2024, subject to regulatory review and approval,” TLX Managing Director and CEO Dr Christian Behrenbruch said.
TLX Chief Development Officer James Stonecypher added that if approved, Zircaix would become the first targeted radiopharmaceutical imaging agent for kidney cancer to ever be commercially available to patients in the US.
The submission builds on the positive outcomes from the company’s global phase three ZIRCON study released in November 2022, which successfully met all co-primary and secondary endpoints and provided a robust foundation for the BLA.
In addition to advancing regulatory processes, Telix has initiated an expanded access program in the US and a named patient program in Europe to extend access to Zircaix beyond clinical trial settings.
TLX shares last traded at $9.78.