Illuccix Gets Expanded FDA Approval for Imaging of Metastatic Prostate Cancer


The expanded indication could facilitate improved access to imaging for patients with metastatic prostate cancer who are candidates for radioligand treatment.

The Food and Drug Administration (FDA) has approved an expanded indication for Illuccix® (Telix Pharmaceuticals) that allows use of the gallium GA 68 gozetotide injection preparation kit for PSMA-guided PET imaging of metastatic prostate cancer to help determine whether patients are candidates for radioligand therapy.1

In order for patients to be considered as viable candidates for targeted radioligand treatment, they need to undergo imaging with an approved gallium-based prostate-specific membrane antigen (PSMA) positron emission tomography (PET) agent, according to Telix Pharmaceuticals. The company added that Pluvicto® (Novartis) is currently the only FDA-approved PSMA-directed radioligand treatment.

“As radioligand therapy for prostate cancer becomes more prevalent, it is critical for doctors to understand who may or may not respond to those treatments. There’s no doubt that appropriate selection of patients for PSMA-targeted radioligand therapy is dependent on appropriate imaging,” emphasized Oliver Sartor, M.D., a professor of medicine and the director of the Tulane Cancer Center at the Tulane University School of Medicine in New Orleans.

(Editor’s note: For related content, see “Recurrent Prostate Cancer and Low PSA Levels: Can an Emerging PSMA PET Agent Have an Impact?” and “Could an Emerging PSMA/PET Imaging Agent Improve the Detection of Recurrent Prostate Cancer?”)

Telix Pharmaceuticals said findings from the phase 3 VISION trial demonstrated the ability of Illuccix to aid in the detection of prostate cancer and help identify patients who may benefit from PSMA-based radioligand therapy.

“Ga-68 PSMA-11 PET was used in the VISION trial and, when used in combination with contrast-enhanced CT, represents a powerful tool for detecting prostate cancer and helping guide patient management,” noted Dr. Sartor, the lead author of the VISION study.2


1. Telix Pharmaceuticals Limited. FDA approves expanded indication for Telix’s Illuccix® to include patient selection for PSMA-directed radioligand therapy. Cision PR Newswire. Available at: . Published March 16, 2023. Accessed March 16, 2023.

2. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385:1091-1103.

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