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FDA approves new indication for Illuccix in metastatic prostate cancer


The PSMA-PET imaging product is now approved for the selection of patients with metastatic prostate cancer for whom 177Lu-PSMA-617 is indicated.

The FDA has approved a supplemental New Drug Application (sNDA) for Illuccix, a radiopharmaceutical cold kit for the preparation of gallium-68 (68Ga) gozetotide (PSMA-11) injection. The PSMA-PET imaging product is now approved for the selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617; Pluvicto) PSMA-directed therapy is indicated.1



"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. 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,” Oliver Sartor, MD, Medical Director at Tulane Cancer Center, stated in a press release.1

The FDA previously approved Illuccix for use following radiolabeling with gallium-68 as a radioactive diagnostic agent for PSMA-PET imaging in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy; or with suspected recurrence based on elevated serum PSA level.2

VISION trial

Illuccix’s new indication means the PSMA-PET imaging product can now be used to determine if a patient is eligible to receive 177Lu-PSMA-617, which, before prescribing requires that the patient receive imaging with an approved gallium-based PSMA-PET agent showing that their tumor has the required level of PSMA expression.

The pivotal VISION trial, which supported the approval of 177Lu-PSMA-617, used Illuccix to help identify patients who met the study criteria for treatment with the PSMA targeted radioligand therapy.

Results from the VISION trial showed that adding 177Lu-PSMA-617 to standard of care (SOC) led to a nearly 40% reduction in the risk of death versus SOC alone in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer.3At a median follow-up of 20.9 months, the addition of LuPSMA improved the median overall survival by 4 months over SOC alone (HR, 0.62). Adding the targeted radioligand therapy also led to a 5.3-month improvement in median radiographic progression-free survival, translating to a 60% reduction in the risk of progression or death (HR, 0.40).

"We welcome the FDA's decision to expand the label indication for Illuccix. This additional indication further demonstrates our continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them. Clinicians now have the ability to use Illuccix in more stages of the patient journey, to confidently and accurately detect and help manage this disease," Kevin Richardson, CEO for Telix Americas, part of Telix Pharmaceuticals, the manufacturer of Illuccix, stated in the press release.1


1. FDA Approves Expanded Indication for Telix's Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy. Published online and accessed March 16, 2023. https://prn.to/40a1v15.

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

3. Morris MJ, De Bono JS, Chi KN, et al. Phase 3 study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). J Clin Oncol 39, 2021 (suppl 15; abstr LBA4).

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