Illuccix Approved by FDA as Prostate Cancer Imaging Agent

Telix Pharmaceuticals’ prostate cancer imaging agent Illuccix has been approved by the FDA to provide PSMA PET imaging for prostate cancer patients across the country. Physicians in Indianapolis, New York City, and Seattle are some of the first to administer the drug to patients.

Typically diagnosed in men over 50, prostate cancer is the second leading cause of cancer death in American men, and the most common cancer in American men after skin cancer. According to the American Cancer Society, more than 268,000 men in this year alone will be diagnosed with prostate cancer across the country, and about 35,000 will die from the disease. Diagnostic tools to both understand the spread of the disease as well as provide individualized treatment are essential for healthcare professionals and treatment teams.

Illuccix is a PSMA PET2 imaging agent designed to help health care professionals diagnose the stage and spread of prostate cancer in patients. The drug is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with suspected metastasis who are candidates for initial definitive therapy, or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

PSMA PET imaging is emerging as a standard of care for prostate cancer patients across the United States and has been included in recent NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer. Dr. Christian Behrenbruch, Group CEO and Managing Director of Telix Pharmaceuticals Limited, noted that “until now, PSMA-PET imaging has had patchy availability and limited patient scheduling flexibility. Illuccix changes this by enabling rapid on-site hospital preparation or convenient delivery from nearby commercial nuclear pharmacies.”

“Early detection and staging can help guide more informed disease management decisions. Tools such as Illuccix PSMA-PET are incredibly valuable as we look for better ways to manage prostate cancer in men,” said Dr. Michael Koch, Professor and Chair of the Department of Urology at the Indiana University School of Medicine and a physician-scientist at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.

117 pharmacies across the country can now order Illuccix, providing coverage for 85 percent of PET imaging sites in the U.S. Telix has plans to increase the number of imaging sites covered during the coming months.


FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix®