FDA Expands Indication for Illuccix for PSMA Radioligand Selection in 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

“[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," according to an expert from Tulane Cancer Center.

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

References

1. FDA approves expanded indication for Telix’s Illuccix® to include patient selection for PSMA-directed radioligand therapy. News release. Telix Pharmaceuticals. March 15, 2023. Accessed March 16, 2023. yhoo.it/3yKztOc
2. FDA approves Telix’s prostate cancer imaging product, Illuccix®. News release. Telix Pharmaceuticals. December 20, 2021. Accessed March 16, 2023.