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FDA Approves Illuccix Gallium Ga-68 Gozetotide Injection for Pre-Taxane Radioligand Therapy in mCRPC

Gallium Ga-68 gozetotide injection is now indicated for use in PET imaging patient selection for radioligand therapy in the pre-taxane setting for mCRPC.

FDA

FDA

The FDA has approved a label expansion for a kit for the preparation of gallium Ga 68 gozetotide injection (Illuccix) to include its use in PET imaging patient selection for radioligand therapy in the pre-taxane setting in patients with metastatic castration-resistant prostate cancer (mCRPC).1

This update applies to the third indication for Illuccix, which is for the selection of patients who are indicated for prostate-specific membrane antigen (PSMA)–directed therapy as described in the prescribing information of each therapeutic product. Illuccix (following radiolabeling with Ga-68) is also indicated for PET of PSMA-positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy or who have suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.

Notably, the label expansion for gallium Ga-68 gozetotide into an earlier treatment setting follows the FDA approval of radioligand therapy for earlier use in the mCRPC disease course. In March 2025, the FDA approved an expanded label for lutetium Lu177 vipivotide tetraxetan (Pluvicto) for use in patients with mCRPC following treatment with an androgen receptor pathway inhibitor in whom it is considered appropriate to delay taxane-based chemotherapy.2

“It is pleasing to see the ability to use gallium [Ga-68] PSMA-PET for patient selection expanded,” Scott T. Tagawa, MD, MS, FACP, FASCO, a professor of medicine and urology at Weill Cornell Medicine; as well as an attending physician at NewYork-Presbyterian – Weill Cornell Medical Center in New York, stated in a news release.1 “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.”

The phase 3 VISION study (NCT03511664) investigated the use of gallium Ga-68 gozetotide to identify PSMA-positive patients in PET imaging to determine eligibility for PSMA-directed therapy.3 In total, 1003 patients with metastatic prostate cancer each received 1 intravenous dose of the imaging agent with radioactivity levels of 167.1 MBq plus or minus 23.1 MBq (4.52 ± 0.62 mCi). Among treated patients, the most commonly reported adverse effects (AEs) were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). AEs that occurred at rates lower than 0.5% included diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

The safety of gallium Ga-68 gozetotide was also assessed in 960 patients from the PSMA-PreRP (NCT03368547 and NCT02919111) and PSMA-BCR (NCT02940262 and NCT02918357) studies who each received 1 dose of the imaging agent. PSMA-PreRP investigated the use of gallium Ga-68 gozetotide in PET scanning of PSMA-positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy. PSMA-BCR investigated the use of the agent in those with suspected recurrence based on elevated serum PSA levels. The average injected activity across both trials was 188.7 MBq plus or minus 40.7 MBq (5.1 ± 1.1 mCi). The most frequently observed AEs were nausea, diarrhea, and dizziness, which each occurring at rates of less than 1%.

“We’re pleased that the US label for Illuccix has been expanded to support patient selection for radioligand therapy in the pre-taxane setting, aligning with the evolving treatment landscape,” Kevin Richardson, chief executive officer of Precision Medicine at Telix, added in the news release.1 “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.”

References

  1. Illuccix approved in U.S. for patient selection for pre-taxane RLT. News release. Telix. June 23, 2025. Accessed June 26, 2025.https://telixpharma.com/news-views/illuccix-approved-in-u-s-for-patient-selection-for-pre-taxane-rlt/
  2. FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication. FDA. March 28, 2025. Accessed June 26, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
  3. Illuccix. Prescribing information. Telix;2025. Accessed June 26, 2025. https://illuccixhcp.com/wp-content/uploads/2025/06/TLX591_USPI_05June2025.pdf

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