FDA Approves TLX591-CDx Prostate Cancer Imaging Product, Making 68Ga-based PSMA-PET More Accessible

The decision by the FDA to approve prostate cancer imaging product TLX591-CDx, a kit to aid in the preparation of gallium-68 gozetotide injections, should make 68Ga-based PSMA-PET more broadly accessible.

Prostate cancer imaging product TLX591-CDx (Illuccix), a kit intended to help with the preparation of gallium-68 (68Ga) gozetotide injections (PSMA-11), has been approved by the FDA, making the use of 68Ga-based prostate-specific membrane antigen (PSMA)–PET more accessible, according to a press release from developer Telix Pharmaceuticals.1

TLX591-CDx is the first commercially available product approved by the FDA that will broaden access to 68Ga-based PSMA-PET imaging for patients within the United States who are eligible to receive it. The product can be prepared through FASTlab cyclotrons or via nuclear pharmacies and healthcare centers utilizing a GalliaPharm or IRE ELIT’s Galli Eo generators.

“The approval of Illuccix will give patients considerably improved access to PSMA-PET imaging, an advanced diagnostic tool that was recently included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer,” Oliver Sartor, MD, medical director at Tulane Cancer Center in New Orleans, Louisiana, said in the press release. “With patient doses able to be prepared on-site or via commercial radiopharmacy networks, either via generator or cyclotron, Illuccix delivers flexible patient scheduling and on-demand access throughout the day.”

Optionality combined with a 4-hour shelf life following radiolabeling with 68Ga allows TLX591-CDx to broaden the reach of PSMA-PET imaging throughout the United States, the developers stated. The distribution network includes 140 nuclear pharmacies, which will help offer TLX591-CDx to 85% of eligible PET imaging sites.

“This heralds a new era of patient and physician access to gallium-based PSMA-PET imaging and marks an important new stage for Telix as we bring our first commercial product to market in the United States,” Christian Behrenbruch, PhD, MBA, managing director and chief executive officer at Telix, stated. “Improved imaging can provide physicians with the insights to determine the most appropriate treatment pathway and give patients in the U.S. access to a specific and sensitive imaging tool for the detection of prostate cancer throughout the body.”

PSMA-11 was approved by the FDA in December 2020 for patients with prostate cancer and PSMA-positive lesions—marking it as the first drug approved for such purposes.2


  1. FDA approves Telix’s prostate cancer imaging product, Illuccix®. News release. Telix Pharmaceuticals. December 20, 2021. Accessed December 20, 2021. https://bit.ly/3smEYRc
  2. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. News release. FDA. December 1, 2020. Accessed December 20, 2021. https://bit.ly/3yKIZzP