FDA Expands Use of Illuccix Kit to Patient Selection for PSMA-Directed Radioligand Therapy

The kit is now approved in the US to select patients with metastatic prostate cancer who are candidates for the only FDA-approved PSMA-directed radioligand therapy.

Officials with the FDA have approved an expanded indication for Telix Americas’ Illucix kit for the preparation of gallium Ga 68 gozetotide injection, enabling its use for the selection of patients with metastatic prostate cancer for whom 177Lu177 prostate-specific membrane antigen (PSMA)-directed therapy is indicated.

Following radiolabeling with Ga 68, Illuccix is indicated for PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy; with suspected recurrence based on elevated serum prostate-specific antigen level; and for selection of patients with metastatic prostate cancer for whom Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

With this expanded label, the kit is now approved in the United States to select patients who are candidates for the only FDA-approved PSMA-directed radioligand therapy, 177Lu-PSMA-617 (Pluvicto; Novartis). To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-positron emission tomography (PET) agent, and the new approval gives physicians new options to get critical information to optimize and guide treatment decisions.

“We welcome the FDA’s decision to expand the label indication for Illuccix,” said Kevin Richardson, MBA, chief executive officer at Telix Americas, in a press release. “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.”

The Illuccix kit was used in the VISION phase 3 study to detect prostate cancer and identify the appropriate patients for PSMA-based radioligand therapy. In this study, 1003 patients received 1 dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 plus or minus 23.1 MBq.

Adverse events (AEs) occurring at 0.5% or more in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). AEs occurring less than 0.5% in the study included diarrhea, dry mouth, and injection site reactions, such as site hematoma and warmth or chills.

According to a press release, an estimated 32,000 patients each year in the United States may be considered for PSMA-directed radioligand therapy.

“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,” said Oliver Sartor, MD, medical director at Tulane Cancer Center, in the press release. “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.”


FDA Approves Expanded Indication for Telix’s Illuccix to Include Patient Selection for PSMA-Directed Radioligand Therapy. News release. Telix. March 16, 2023. Accessed March 17, 2023. https://telixpharma.com/news-views/fda-approves-expanded-indication-for-telixs-illuccix-to-include-patient-selection-for-psma-directed-radioligand-therapy/

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