Illuccix is FDA Approved to Guide Radioligand Use in Prostate Cancer

Illuccix is now FDA approved to help select patients with metastatic prostate cancer for radioligand therapy before chemotherapy: © stock.adobe.com.

The U.S. Food and Drug Administration (FDA) has approved a label expansion for Illuccix — a kit for the preparation of gallium Ga-68 gozetotide, for injection — to help choose patients with metastatic castration-resistant prostate cancer for radioligand therapy (RLT) in the pre-taxane setting, according to a news release from Telix.

“It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded,” Dr. Scott T. Tagawa said in the news release. “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.”

Tagawa is a genitourinary oncologist. He serves as a professor of Medicine and Urology at Weill Cornell Medicine, and an attending physician at NewYork-Presbyterian, Weill Cornell Medical Center

The update expands Illuccix’s use to help identify patients eligible for prostate-specific membrane antigen (PSMA)–directed therapy, as outlined in the prescribing information of those treatments. This label change follows the FDA’s expanded approval of Pluvicto (lutetium Lu177 vipivotide tetraxetan) for men with metastatic castration-resistant prostate cancer who have received androgen receptor pathway inhibitor therapy but not yet chemotherapy. Now that this therapy can be used earlier, Illuccix scans are expected to increase by more than 20,000 annually, as per the release.

“We’re pleased that the U.S. label for Illuccix has been expanded to support patient selection for RLT in the pre-taxane setting, aligning with the evolving treatment landscape,” Kevin Richardson, chief executive officer, Precision Medicine, Telix, said in the news release. “PSMA-PET imaging has become a standard of care in the detection and management of prostate cancer. With this update, patients can now benefit from the high diagnostic accuracy of Illuccix to identify those most likely to respond to PSMA-targeted therapy, even earlier in their treatment journey.”

Safety Information of Pluvicto

Illuccix PET imaging may produce false-positive or false-negative results. Uptake of gallium Ga 68 gozetotide is not specific to prostate cancer and may occur with other cancers or noncancerous conditions. Clinical correlation, including possible biopsy, is recommended. Imaging performance may vary based on prostate-specific antigen (PSA) levels, site of disease or Gleason score. Gallium Ga 68 gozetotide adds to long-term radiation exposure, which may increase cancer risk. Patients should hydrate and void frequently.

Side effects reported in trials included nausea, diarrhea, dizziness, fatigue, constipation and vomiting, most occurring in fewer than 1% of patients. Safe handling is important to limit radiation exposure.

Previous FDA Approval of Pluvicto

The FDA previously approved Pluvicto for adults with PSMA-positive metastatic castration-resistant prostate cancer who had previously received androgen receptor pathway inhibitors and taxane-based chemotherapy. Pluvicto became the first targeted radioligand therapy approved for this patient population. It combined a molecule that targeted PSMA with a radioactive component, delivering treatment directly to cancer cells and nearby tissue.

The approval was based on results from the phase 3 VISION trial, which showed that adding Pluvicto to standard treatment improved overall survival by four months compared to standard care alone. It also delayed disease progression and reduced the risk for progression or death by 60%.

In an interview with CURE, Dr. Richard Wahl, president of the Society of Nuclear Medicine and Molecular Imaging and director of the Mallinckrodt Institute of Radiology at Washington University School of Medicine in St. Louis recently discussed the impact that Pluvicto’s approval can have for this group of patients.

Common side effects reported during the trial included fatigue, dry mouth, anemia, nausea, constipation and decreased appetite.

According to the FDA approval, this marked a major step forward in precision medicine for prostate cancer. The approval also included Locametz, an imaging agent used to identify PSMA-positive tumors via PET scan, helping clinicians determine whether patients were eligible for treatment with Pluvicto.

At the time, experts noted that the approval addressed a high unmet need among patients with advanced prostate cancer who had limited options.

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