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First patient receives newly-approved PSMA-PET imaging product


The first commercial patient has been treated with TLX591-CDx (Illuccix), an FDA-approved1 radiopharmaceutical cold kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection.2

The imaging agent 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.3 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.

"Early detection and staging can help guide more informed disease management decisions. Tools such as Illuccix PSMA-PET are incredibly valuable as we look for better ways to manage prostate cancer in men," Michael Koch, MD, professor and chair of the Department of Urology at the Indiana University School of Medicine and a physician-scientist at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center, stated in a news release.

Mark Green, PhD, director of Radiopharmaceutical Sciences and professor of Radiology & Imaging Sciences at the Indiana University School of Medicine, added in the news release, "The success of Telix in gaining FDA-approval for kit-formulated 68Ga-PSMA-11 represents an innovation for prostate cancer patients. Telix is providing a much-needed avenue for widespread clinical access to PSMA-targeted PET for improved understanding of the location and extent of a patient's disease. These imaging insights can be important as the physician develops an individualized treatment plan."

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 imaging agent.

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 68Ga-PSMA-11. Of the patients who went on to undergo surgery, 68Ga-PSMA-11 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 68Ga-PSMA-11 in at least 1 body region. In total, 91% of patients with positive 68Ga-PSMA-11 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.


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

2. First Patients Dosed with Illuccix® - Telix's Approved Prostate Cancer Imaging Agent. Published online April 14, 2022. Accessed April 14, 2022. https://prn.to/3KLLcAb

3. 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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