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FDA approves novel PSMA-PET imaging product for prostate cancer


The FDA has approved TLX591-CDx (trade name, Illuccix), a radiopharmaceutical cold kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection.1

68Ga PSMA-11 was previously approved by the FDA as the first drug for PET-imaging of PSMA-positive lesions in men with prostate cancer.2 Specifically, 68Ga PSMA-11 is indicated for patients with suspected metastasis who are eligible for initial definitive therapy, or patients with suspected recurrence due to an elevated PSA level.

“Illuccix can be prepared with 68Ga via either GE’s FASTlabTM cyclotrons or in nuclear pharmacies and healthcare centers across the country using Eckert & Ziegler’s GalliaPharm®generator or IRE ELIT’s Galli Eo® generator. This optionality, along with a four-hour shelf life after radiolabeling with 68Ga, enables Illuccix to flexibly extend the reach of advanced PSMA-PET imaging to patients across the country,” Telix, the manufacturer of TLX591-CDx, explained in a news release.

A. Oliver Sartor, MD

A. Oliver Sartor, MD

Commenting on the approval in the news release, A. Oliver Sartor, MD, Medical Director at Tulane Cancer Center, stated, “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 for Prostate Cancer. 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.”

Clinical support for 68Ga PSMA-11

The FDA approved 68Ga PSMA-11 based on the safety and efficacy of the treatment proven in 2 prospective clinical trials with a total of 960 men with prostate cancer who each received 1 injection of the drug.

In the first trial, 325 patients who were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis underwent PET/CT or PET/MRI scans performed with Ga 68 PSMA-11. Of the patients who went on to undergo surgery, Ga 68 PSMA-11 PET demonstrated a clinically important rate of metastatic cancer confirmed by surgical pathology in patients with positive readings in the pelvic lymph nodes.

In the second trial, 635 patients who had rising serum PSA levels after initial prostate surgery or radiotherapy, 74% had at least 1 positive lesion detected by Ga 68 PSMA-11 PET in at least 1 body region. In total, 91% of patients with positive Ga 68 PSMA-11 PET readings who had correlative tissue pathology from biopsies, who also had results from baseline or follow-up imaging by conventional methods, and serial PSA levels available for comparison, also had local recurrence or metastasis of prostate cancer confirmed.

Christian Behrenbruch, PhD, managing director and CEO at Telix, shared his thoughts on the approval of TLX591-CDx in the news release: “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,” “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.”


1. FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix. Published online December 20, 2021. Accessed December 20, 2021. https://bit.ly/3J8Wgan

2. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. Press release. FDA. December 1, 2020. Accessed December 1, 2020. https://bit.ly/3fWUOcN

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