Use of a kit that prepares for gallium Ga 68 gozetotide injection in the phase 3 VISION study affirms its ability to identify patients who are suitable to receive PSMA-based radioligand for metastatic prostate cancer.
The FDA has approved an expanded indication for Illuccix (TLX591-CDx), a kit that prepares for Ga-68 PSMA-11 PET injection, to allow for the selection of patients with metastatic prostate cancer who may benefit from prostate-specific membrane antigen (PSMA)–directed radioligand 177Lu-PSMA-617 (Pluvicto), according to a press release from Telix Pharmaceuticals.1
The expanded label will better allow for patient selection, help inform treatment strategies, and optimize outcomes. Investigators used Illuccix in the phase 3 VISION study (NCT03511664) to help doctors detect prostate cancer and determine which patients were eligible for PSMA-based radioligand therapy.
“There's no doubt that appropriate selection of patients for PSMA-targeted radioligand therapy is dependent on appropriate imaging,” Oliver Sartor, MD, medical director at Tulane Cancer Center, said in the press release. “[Illuccix] 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 manage patients.”
Illuccix is a kit for preparing injections with gallium-68 gozetotide (PSMA-11), a radioactive diagnostic agent indicated for PET scans of PSMA-positive lesions in patients with prostate cancer.
Investigators of the international, prospective, open-label phase 3 VISION study evaluated 177Lu-PSMA-617 plus best standard of care vs standard of care alone in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer. Patients either received best supportive care as determined by the investigator with or without 177Lu-PSMA-617 given intravenously once every 6 weeks for a maximum of 6 cycles.
The primary end points of the trial included radiographic progression-free survival and overall survival. Secondary end points included overall response rate, disease control rate, and duration of response.
Patients 18 years or older with an ECOG performance status of 0 to 2 and a life expectancy of more than 6 months were eligible for enrollment on the trial. Additional inclusion criteria included having 1 or metastatic lesion present on baseline CT, MRI, or bone scan, as well as adequate organ function.
Patients who received any systemic anti-cancer therapy within 28 days prior to treatment randomization were not eligible for enrollment on the trial. Patients were also unsuitable for enrollment if they had a history of central nervous system metastases, symptomatic cord compression, or known hypersensitivity to the components of 177Lu-PSMA-617 or its analogs.
The FDA originally approved Illuccix to improve access to PSMA-PET imaging in December 2021.2