FDA Grants Expanded Approval for Illuccix in Patient Selection for Pre-Taxane Radioligand Therapy

The Food and Drug Administration (FDA) has approved a third indication for Illuccix, a preparation kit for gallium Ga-68 gozetotide, which enables use for prostate cancer (PCa) patients being considered for pre-taxane radioligand therapy.

Estimating that the new indication may increase the use of Illuccix by up to 20,000 additional PSMA PET scans a year, Telix Pharmaceuticals, the manufacturer of Illuccix, suggested that expand access to PSMA PET imaging could lead to earlier treatment intervention for men with PCa.

“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,” noted Scott T. Tagawa, M.D., a genitourinary oncologist and professor of medicine and urology at Weill Cornell Medicine in New York City.

In combination with Ga 68 radiolabeling, Illuccix was previously indicated for PET imaging of PSMA-positive lesions in men with suspected PCa metastasis who are candidates for definitive therapy and those with suspected PCa recurrence due to elevated prostate-specific antigen (PSA) levels.