Telix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (gallium Ga-68 gozetotide), broadening its use for patient selection for radioligand therapy (RLT) in the pre-taxane setting for prostate cancer. This significant update means Illuccix can now be used earlier in the treatment pathway for men with metastatic castration-resistant prostate cancer (mCRPC), specifically after treatment with an androgen receptor pathway inhibitor (ARPI) therapy but before chemotherapy. This aligns with the FDA's recent approval of Pluvicto® (lutetium Lu177 vipivotide tetraxetan) for earlier use in mCRPC, and is expected to increase Illuccix's clinical utilization by at least 20,000 scans annually.

Illuccix is a positron emission tomography (PET) agent used to identify prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer, including those with suspected metastasis, suspected recurrence, and now for selecting patients suitable for PSMA-directed therapy in this earlier pre-taxane stage.

While offering crucial diagnostic capabilities, important safety information notes the risk for misinterpretation, as a negative scan doesn't rule out cancer and positive uptake isn't exclusive to prostate cancer. Clinical correlation, including histopathological evaluation, is recommended. Patients should also be aware of radiation risks associated with long-term cumulative exposure and should hydrate and void frequently after administration to minimize exposure.

The safety profile of Illuccix, based on studies with over 1,900 patients, shows that commonly reported adverse reactions are rare, occurring at less than 1%, and include nausea, diarrhea, dizziness, fatigue, constipation, and vomiting. Less common side effects observed were dry mouth and injection site reactions. The prescribing information also cautions that androgen deprivation therapy and other androgen pathway-targeting therapies can affect Illuccix uptake, though the full impact on PET performance in these cases is not yet established.