Ga-68 Kit Approved for Pre-Taxane RLT Selection in mCRPC

This label expansion is applicable to Illuccix's third approved indication.

The FDA has approved a label expansion for Illuccix to include the selection of patients eligible for radioligand therapy (RLT) who have not yet received taxane-based chemotherapy, according to an announcement from Telix Pharmaceuticals Limited, the developer of Illuccix.¹

Illuccix is a preparation kit for injectable gallium Ga-68 gozetotide.

This expansion pertains to the product’s third indication for the selection of prostate-specific membrane antigen (PSMA)-directed therapies and follows the expansion of lutetium Lu 177 vipivotide tetraxetan’s (177Lu-PSMA-617; Pluvicto) label to include PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).^1,2

177Lu-PSMA-617’s label expansion is applicable to adult patients who have received prior androgen receptor pathway inhibitor (ARPI) therapy and are candidates to delay taxane-based chemotherapy.¹

Following radiolabeling with gallium-68, Illuccix can be used for positron emission tomography (PET) of PSMA-positive lesions for those with prostate cancer. The FDA has approved its use in patients with suspected metastasis who are candidates for initial definitive therapy, suspected recurrence per elevated serum prostate-specific (PSA) level, or potential to benefit from PSMA-directed therapy.

As stated in the release issued by Telix, Illuccux’s ability to image biochemically recurrent prostate cancer appears to be affected by serum PSA levels as well as disease site. Additionally, its use in imaging metastatic pelvic lymph nodes before initial definitive therapy appears to be affected by Gleason score.

“It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded,” said Scott T. Tagawa, MD, MD, FACP, FASCO. “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 professor of medicine and urology at Weill Cornell Medicine and attending physician at NewYork-Presbyterian – Weill Cornell Medical Center in New York, New York.

When will oncology nurses use Illuccix?

Notably, Illuccix will be used in the selection of taxane-naive patients eligible for treatment with 177Lu-PSMA-617. Prior to the expansion of labels for both Illuccix and 177Lu-PSMA-617, the products were approved for use following an ARPI and taxane-based chemotherapy.^1,2 RLTs combine radioisotopes with targeting ligands to deliver cytoxic radiation to patients.

Are there safety concerns with Illuccix?

The recommended amount of radioactivity to be administered in adult patients for PET is 111 MBq to 259 MBq intravenously as a bolus injection. Illuccix’s label includes a warning for radiation; health care professionals handling Illuccix should take necessary precautions to avoid radiation exposure and prevent unnecessary exposure for patients.³

The most common adverse events (AEs) associated with Illuccix, occurring in at least 0.5% of patients, are fatigue, nausea, constipation, and vomiting. However, in clinical trials these occurred in fewer than 1% of patients.

What uses of RLT and Illuccix are on the horizon?

In addition to its indications already approved in mCRPC, 177Lu-PSMA-617 was found to extend overall survival (OS) and improve quality of life (QOL) when used in combination with enzalutamide (Xtandi) in patients with mCRPC at high risk for early treatment failure on enzalutamide monotherapy, according to findings from the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.⁴

The combination reduced the risk of death by 45% vs enzalutamide alone with a median OS of 34 months (95% CI, 30-37) vs 26 months (95% CI, 23-31) with enzalutamide monotherapy (HR, 0.55; 95% CI, 0.36-0.84; P = .005).

Median deterioration-free survival (DFS) for physical function for patients taking the investigational combination was 10.6 months compared with 3.4 months for those receiving monotherapy (HR, 0.51; 95% CI, 0.36-0.72; P = .0001). The median DFS for overall health status was 8.7 vs 3.3 months, respectively (HR, 0.47; 95% CI, 0.33-0.67; P < .0001).

Additionally, the mean scores for pain until progression (difference 7.3; 95% CI, 1.6-13; P = .01) and mean score for fatigue until progression (difference 5.9; 95% CI, 1.1-11; P = .02) both were improved with the combination compared with enzalutamide alone.

References

1. Illuccix approved in U.S. for patient selection for pre-taxane RLT. Telix Pharmaceuticals Limited. News release. June 23, 2025. Accessed June 24, 2025. https://www.globenewswire.com/news-release/2025/06/23/3103271/0/en/Illuccix-Approved-in-U-S-for-Patient-Selection-for-Pre-Taxane-RLT.html
2. FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication. FDA. March 28, 2025. Accessed June 24, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
3. Gallium Ga-68 gozetotide (Illuccix). Prescribing information. Telix; 2020. Updated March 2023. Accessed June 24, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214032s001lbl.pdf
4. Emmett L, Subramaniam S, Crumbaker M, et al. Overall survival and quality of life with [177Lu] Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in poor-risk, metastatic, castration-resistant prostate cancer in ENZA-p (ANZUP 1901). J Clin Oncol. 2025;43(suppl 5):17. doi: 10.1200/JCO.2025.43.5_suppl.17