FDA expands Illuccix label to include patient selection for RLT in pre-taxane setting

The FDA has approved a label expansion for Illuccix (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include use in patient selection for prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) in patients with prostate cancer who have not received prior taxane-based chemotherapy.¹

Prior approvals of Illuccix have been supported by findings from the phase 3 VISION trial.

Illuccix, after radiolabeling with Ga 68, is approved in the US for PET imaging of PSMA-positive lesions in patients with prostate cancer:

• With suspected metastasis who are candidates for initial definitive therapy,
• With suspected recurrence based on elevated prostate-specific antigen (PSA) level,
• And for the selection of patients who are indicated for PSMA-directed RLT therapy

According to Telix Pharmaceuticals, “The update applies to Illuccix’s third indication, for selection of patients who are indicated for PSMA-directed therapy as described in the Prescribing Information of the therapeutic products.”

“It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded,” said Scott T. Tagawa, MD, MS, FACP, FASCO, a genitourinary oncologist at Weill Cornell Medicine in New York, in the 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 label expansion comes on the heels of the FDA approval of an expanded label for ¹⁷⁷Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto) in March 2025 to include use in the pre-taxane setting. Specifically, ¹⁷⁷Lu-PSMA-617 was approved for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

According to Telix, “With RLT now approved for use earlier in the patient journey, the clinical utilization of Illuccix is expected to increase by at least 20,000 scans annually.”

The expanded approval of ¹⁷⁷Lu-PSMA-617 was supported by positive data from the phase 3 PSMAfore trial (NCT04689828), which showed that the RLT prolonged radiographic progression-free survival (rPFS) compared with a change in ARPI in patients with PSMA-positive mCRPC who had progressed on a previous ARPI.³ Specifically, the median rPFS was 11.6 months (95% CI, 9.30 to 14.19) among patients who received ¹⁷⁷Lu-PSMA-617 vs 5.6 months (95% CI, 4.21 to 5.95) among patients who received a change in ARPI, translating to a 59% reduction in the risk of radiographic progression or death (HR, 0.41; 95% CI, 0.29 to 0.56; P < .0001).

“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,” said Kevin Richardson, CEO, Precision Medicine at Telix, 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.”

Data on Illuccix

Prior approvals of Illuccix, including its FDA approval in March 2023 for selection of patients with metastatic prostate cancer for whom PSMA-directed therapy (¹⁷⁷Lu-PSMA-617) is indicated, have been supported by findings from the phase 3 VISION trial (NCT03511664). In this study, Illuccix was used to identify patients who met the study criteria for treatment with ¹⁷⁷Lu-PSMA-617, which, before prescribing requires that the patient receive imaging with an approved gallium-based PSMA-PET agent showing that their tumor has the required level of PSMA expression.

Overall, data from the VISION trial demonstrated that treatment with ¹⁷⁷Lu-PSMA-617 plus standard of care (SOC) extended imaging-based progression-free survival (PFS) and overall survival (OS) vs SOC alone in patients with PSMA-positive mCRPC. PSMA-positive status in the study was determined by ⁶⁸Ga-PSMA-11 PET/CT scans.

At a median follow-up of 20.9 months, the median PFS with ¹⁷⁷Lu-PSMA-617 plus SOC was 8.7 months, compared with 3.4 months with SOC alone (HR, 0.40; 99.2% CI, 0.29 to 0.57; P < .001). Similarly, the median OS was 15.3 months with ¹⁷⁷Lu-PSMA-617 plus SOC vs 11.3 months with SOC alone (HR, 0.62; 95% CI, 0.52 to 0.74; P < .001).

Results from the trial’s key secondary end points of objective response, disease control, and time to symptomatic skeletal events also favored the ¹⁷⁷Lu-PSMA-617 arm.

Regarding safety, 52.7% of patients in the ¹⁷⁷Lu-PSMA-617 plus SOC arm experienced an adverse event of grade 3 or higher compared with 38.0% of patients in the SOC alone arm. Quality of life did not appear to be adversely affected in the ¹⁷⁷Lu-PSMA-617 cohort.

In total, the international, open-label trial included 831 patients with a PSMA-positive metastatic lesion who were randomly assigned 2:1 to receive ¹⁷⁷Lu-PSMA-617 plus SOC or SOC alone. Baseline characteristics were well-balanced between the 2 arms. The primary end points were imaging-based PFS and OS.

REFERENCES

1. Illuccix approved in U.S. for patient selection for pre-taxane RLT. News release. Telix Pharmaceuticals. Published online and accessed June 23, 2025. https://telixpharma.com/news-views/illuccix-approved-in-u-s-for-patient-selection-for-pre-taxane-rlt/

2. FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. News release. Novartis Pharma AG. March 28, 2025. Accessed June 23, 2025. https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer

3. Morris MJ, Castellano D, Herrmann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. Lancet. 2024;404(10459):1227-1239. doi:10.1016/S0140-6736(24)01653-2

4. Sartor O, de Bono J, Chi KN, et al. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322