FDA Approves New Indication for Illuccix to Include Patient Selection

By Emily Menendez - Last Updated: March 16, 2023

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Illuccix, Telix Pharmaceuticals’ prostate cancer imaging kit. The sNDA will enable the use of Illuccix to aid in the selection of patients with metastatic prostate cancer for whom radioligand therapy is indicated.

After radiolabeling with gallium (68Ga), Illuccix is used for the preparation of 68Ga gozetotide injections for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer who have suspected metastasis and are suitable for initial definitive therapy, or who have suspected recurrence with elevated serum prostate-specific antigen levels. The phase 3 VISION study utilized Illuccix to identify appropriate patients to undergo PSMA-based radioligand therapy, and positive results from the trial led to FDA approval.

The only FDA-approved, PSMA-directed radioligand therapy currently available is 177Lu-PSMA-617 (Pluvicto). To qualify for it, patients must undergo imaging with an approved gallium-based PSMA PET agent. The new indication for Illuccix will improve access to imaging for approximately 32,000 candidates for radioligand therapy in the United States.

Kevin Richardson, chief executive officer for Telix Americas, said, “We welcome the FDA’s decision to expand the label indication for Illuccix. This additional indication further demonstrates our continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them. Clinicians now have the ability to use Illuccix in more stages of the patient journey, to confidently and accurately detect and help manage this disease.”