Telix Pharmaceuticals Limited (TLX) announced on Friday that Health Canada has approved an extension to the label of its prostate cancer imaging product, Illuccix. This extension allows its use in selecting patients for PSMA-targeted radionuclide therapy.
Illuccix is a kit designed for the preparation of gallium-68 gozetotide, also known as PSMA-11, injection. It serves as a radioactive diagnostic agent used in positron emission tomography (PET) for identifying prostate-specific membrane antigen (PSMA) positive lesions in prostate cancer patients.
With this label expansion, Illuccix is now authorized for use in identifying patients with progressive metastatic castration-resistant prostate cancer (mCRPC) for treatment with Pluvicto, the sole approved PSMA-targeted radionuclide therapy. Eligibility for this therapy requires imaging with an authorized gallium-based PSMA-PET agent, such as Illuccix.