Telix Granted TGA Priority Review for Prostate Cancer Imaging

Melbourne (Australia) – 7th December 2020. Telix has been granted Priority Review status for TLX591-CDx (⁶⁸Ga-PSMA-11), a radiopharmaceutical for the imaging of prostate cancer using Positron Emission Tomography (PET).

Telix Pharmaceuticals is pleased to announce that its application for a Therapeutic Goods Administration (TGA) determination for its prostate cancer imaging product TLX591-CDx (⁶⁸Ga-PSMA-11), a radiopharmaceutical for the imaging of prostate cancer using Positron Emission Tomography (PET), has been granted Priority Review status. This important outcome grants Telix a significantly accelerated timeframe of 150 working days for product dossier review and approval.

In addition, a Medical Services Advisory Committee (MSAC) application is already in progress and Telix expects that MSAC approval and commercial availability of TLX591-CDx should coincide around May-June of 2021, subject to TGA review and approval.

Telix CEO, Dr. Chris Behrenbruch stated: “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.”

To read the full ASX release please click here.