FDA Expands Illuccix Label to Identify Patients for Treatment with Pluvicto

The FDA has approved Telix Pharmaceutical’s supplementary new drug application (sNDA) for Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) to include identifying patients who would benefit from treatment with Pluvicto (lutetium Lu 177 vipivotide tetraxetan). Pluvicto is a radiopharmaceutical used to treat patients with advanced prostate cancer that was developed by Advanced Accelerator Applications, now a part of Novartis.

Illuccix is for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Telix launched Illuccix in April 2022. For 2022, the company reported global revenue for Illuccix of $149.7 million, which represents sales for the first nine months after the product’s launch.

Oliver Sartor, M.D.

“As radioligand therapy for prostate cancer becomes more prevalent, it is critical for doctors to understand who may or may not respond to those treatments,” Oliver Sartor, M.D., medical director at Tulane Cancer Center, said in a press release. “There’s no doubt that appropriate selection of patients for PSMA targeted radioligand therapy is dependent on appropriate imaging. Ga-68 PSMA-11 PET was used in the VISION trial and, when used in combination with contrast-enhanced CT, represents a powerful tool for detecting prostate cancer and helping guide patient management.”