TGA grants priority review for Telix Pharmaceuticals' TLX591-CDx

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The TGA has granted Telix Pharmaceuticals' (ASX:TLX) prostate cancer imaging product TLX591-CDx priority review status.

TLX591-CDx is a radiopharmaceutical for the imaging of prostate cancer using Positron Emission Tomography (PET).

Priority review grants the company a significantly accelerated timeframe of 150 working days for product dossier review and approval.

The company’s preliminary application to the TGA for TLX591-CDx was made at the same time as it submitted a New Drug Application (NDA) submission to the US FDA. The company made a submission to the European regulator in April 2020.

Telix said a Medical Services Advisory Committee (MSAC) application is already in progress.

According to Telix CEO, Dr Chris Behrenbruch, “As an Australian headquartered company, we are especially delighted that the TGA has granted Priority Review for TLX591-CDx, bringing us one step closer to providing a commercially available prostate imaging agent to patients in our own backyard.

"This is an important development for urologic oncology in Australia as a properly validated and commercially available product will ensure far greater patient access and confidence in the technology, currently only available on a limited basis under 'special access' use from a relatively small number of academic nuclear medicine departments around the country.”