December 21, 2021 – Telix Pharmaceuticals Limited announced that the FDA has approved Telix’s lead prostate cancer imaging product, Illuccix. Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer with:
- suspected metastasis who are candidates for initial definitive therapy
- suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
Illuccix is the first commercially available FDA-approved product to enable wide accessibility to 68Ga- based PSMA-PET imaging for physicians and eligible patients across the United States.
Illuccix can be prepared with 68Ga via either GE’s FASTlab cyclotrons or in nuclear pharmacies and healthcare centers across the country using Eckert & Ziegler’s GalliaPharm generator or IRE ELIT’s Galli Eo generator. This optionality along with a four-hour shelf life after radiolabeling with 68Ga, enables Illuccix to flexibly extend the reach of advanced PSMA-PET imaging to patients across the country, the company says.
With a distribution network encompassing more than 140 nuclear pharmacies through its agreements with Cardinal Health and PharmaLogic, Telix will be able to provide Illuccix to more than 85% of eligible PET imaging sites throughout the United States.