FDA Approves New PSMA PET Imaging Product for Prostate Cancer

Telix Pharmaceuticals today announces that the US Food and Drug Administration (FDA) has approved the company’s lead prostate cancer imaging asset, called Illuccix®.

Illucix is a preparation kit for gallium-68 PSMA-11 injection, an agent indicated for PET PSMA position tumors in patients with suspected prostate cancer metastasis who are eligible for initial definitive therapy and have suspected cancer recurrence based on elevated PSA levels.

The approval of Illuccix will give patients considerably improved access to PSMA-PET imaging, an advanced diagnostic tool that was recently included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) 1 for Prostate Cancer,” said Dr. Oliver Sartor, Medical Director at Tulane Cancer Center via a press release. “With patient doses able to be prepared on-site or via commercial radiopharmacy networks, either via generator or cyclotron, Illuccix delivers flexible patient scheduling
and on-demand access throughout the day.”

The kit is the first commercially available FDA-approved product for gallium-68 based PSMA-PET imaging for physicians and eligible patients across the United States.