The U.S. Food and Drug Administration (FDA) has approved a label expansion of a kit for the preparation of gallium Ga-68 gozetotide for injection (Illuccix) to include patient selection for radioligand therapy in the pre-taxane setting.
The update applies to the imaging agent’s third indication, for selection of patients who are indicated for prostate-specific membrane antigen (PSMA)-directed therapy. The label expansion follows the FDA’s March 2025 approval of an expanded label for lutetium Lu-177 vipivotide tetraxetan (Pluvicto) for use in patients with metastatic castration-resistant prostate cancer after treatment with an androgen receptor pathway inhibitor and before chemotherapy.
With radioligand therapy now approved for use earlier in the patient journey, the clinical use of Ga-68 gozetotide is expected to increase by at least 20,000 scans annually.
Indications and Use
After radiolabeling with Ga-68 gozeotide, this kit is indicated for positron-emission tomography (PET) of PSMA-positive lesions in the following men with prostate cancer:
- Those with suspected metastasis who are candidates for initial definitive therapy;
- Those with suspected recurrence based on elevated serum prostate-specific antigen level;
- Those who are indicated for PSMA-directed therapy as described in the Prescribing Information of the therapeutic products.
Scott T. Tagawa, MD, MS, FACP, FASCO, Professor of Medicine and Urology at Weill Cornell Medicine and an Attending Physician at NewYork–Presbyterian–Weill Cornell Medical Center, shared these comments: “It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded. This empowers clinicians to make more informed, personalized decisions earlier in the disease course and access life-prolonging targeted radionuclide therapy for more patients with prostate cancer.”
