Telix Pharmaceuticals (Melbourne, Australia; Indianapolis, IN) announced on December 20 that the U.S. Food and Drug Administration (FDA) had approved Illucix (TLX591-CDx), the company’s kit for preparation of 68Ga-gozetotide (68Ga–prostate-specific membrane antigen [PSMA]-11). The product is approved for PET imaging in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or in whom recurrence is suspected based on elevated serum prostate-specific antigen levels.
The FDA first approved 68Ga-PSMA-11 PET for prostate cancer imaging in December 2020, but access was available only through the University of California Los Angeles and the University of California San Francisco. “The approval of Illuccix will give patients considerably improved access to PSMA PET imaging, an advanced diagnostic tool that was recently included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Prostate Cancer,” said A. Oliver Sartor, MD, Medical Director of the Tulane Cancer Center (New Orleans, LA). “With patient doses able to be prepared onsite or via commercial radiopharmacy networks, either via generator or cyclotron, Illuccix delivers flexible patient scheduling and on-demand access throughout the day.”
According to a Telix press release issued on December 20, Illuccix can be prepared with 68Ga via either GE’s FASTlab cyclotrons or in nuclear pharmacies and health care centers using the Eckert and Ziegler GalliaPharm generator or the IRE ELiT Galli Eo generator. Along with a 4-hour shelf life after radiolabeling, these generation options will allow expansion of PSMA PET in prostate cancer. “This product offers a level of flexibility and accessibility to health care professionals we really haven’t seen before in this class of products and may help us provide better patient experiences as a result,” said Dr. Sartor. With a distribution network encompassing more than 140 nuclear pharmacies through an agreement with Cardinal Health and PharmaLogic, Telix noted that Illuccix will be available to more than 85% of eligible PET imaging sites in the United States.
Telix Pharmaceuticals
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