Telix Pharmaceuticals has secured clearance from the U.S. Food and Drug Administration (FDA) for its Illuccix gallium-68 gozetotide prostate cancer PET imaging agent.
Illucix is indicated for patients with suspected prostate cancer metastasis who are eligible for initial therapy and those with suspected recurrence based on elevated prostate-specific antigen levels. It can be prepared using either GE Healthcare's FASTlab cyclotrons or in nuclear pharmacies with Eckert & Ziegler Radiopharma's GalliaPharm generator or Belgian radiopharmaceutical developer Institute for Radioelements - Environment and Life Science Technology's (IRE-ELiT) Galli Eo generator, the company said.