Telix Pharmaceuticals has announced that the Australian Therapeutic Goods Administration (TGA) and Health Canada have approved expanded indications for Illuccix, a gallium-68 gozetotide injection, to include patient selection for prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy. These approvals mark a significant step forward in the theranostic approach to managing prostate cancer, enabling clinicians to better identify patients who are likely to benefit from PSMA-targeted treatments like lutetium-177 vipivotide tetraxetan (Pluvicto).
Australian Approval for PSMA-Targeted Therapy Selection
The Australian TGA has approved Illuccix for selecting patients with metastatic prostate cancer for treatment with PSMA-targeted radionuclide therapy. This approval expands the clinical utility of Illuccix, which has been available in Australia since November 2021 for initial staging of intermediate to high-risk prostate cancer and restaging of recurrent prostate cancer. According to the Prostate Cancer Foundation of Australia, approximately 26,368 men are expected to be diagnosed with prostate cancer in 2024, with around 4,000 having Stage III or IV metastatic disease.
Professor Andrew Scott AM, Director of the Department of Molecular Imaging and Therapy at Austin Health, Melbourne, noted that Telix's PSMA-PET agent was used in the VISION trial to detect prostate cancer and identify appropriate patients for PSMA-targeted radionuclide therapy with lutetium-177 vipivotide tetraxetan. Raphaël Ortiz, CEO of Telix International, emphasized that Illuccix is now registered on the Australian Register of Therapeutic Goods (ARTG) for broader use, ensuring that patients have access to a rigorously evaluated PSMA-PET imaging agent.
Canadian Approval for mCRPC Patient Selection
Health Canada has also approved Illuccix for selecting patients with progressive metastatic castration-resistant prostate cancer (mCRPC) for treatment with lutetium (177Lu) vipivotide tetraxetan (Pluvicto). This approval expands Illuccix's utility, as it has been approved in Canada since October 2022 for staging and re-staging intermediate and high-risk prostate cancer, and localizing tumor tissue in recurrent prostate cancer.
Dr. Francois Lamoureux, President of the Canadian Association of Nuclear Medicine, highlighted the importance of identifying patients who may respond to targeted radionuclide therapies. He noted that 68Ga-PSMA-11 PET/CT was shown to be a powerful tool in the VISION trial for detecting prostate cancer and informing patient management. André Gagnon, President of Isologic, added that PSMA-targeted theranostics are widely considered the future of prostate cancer treatment, making the expanded availability of Illuccix a significant advancement.
Clinical Significance and the VISION Trial
The approvals are supported by data from the Phase 3 VISION trial (NCT03511664), a randomized, open-label, multicenter study that evaluated the efficacy and safety of lutetium-177 PSMA-617 (Lu-PSMA-177) plus best standard of care (BSoC) versus BSoC alone in men with PSMA-positive mCRPC who had progressed despite prior treatment with androgen receptor pathway inhibitors. The trial demonstrated that Lu-PSMA-177 plus BSoC significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) compared to BSoC alone.
In the VISION trial, patients were selected based on PSMA expression detected by PET diagnostic imaging using 68Ga-PSMA-11. The median OS was 15.3 months in the Lu-PSMA-177 arm compared to 11.3 months in the BSoC arm (HR, 0.62; 95% CI, 0.52 to 0.74; P < .001). The median rPFS was 8.7 months in the Lu-PSMA-177 arm compared to 3.4 months in the BSoC arm (HR, 0.40; 99.2% CI, 0.29 to 0.57; P < .001).
Implications for Prostate Cancer Management
The expanded approvals for Illuccix in Australia and Canada represent a significant advancement in the management of prostate cancer. By enabling clinicians to accurately identify patients who are most likely to respond to PSMA-targeted radionuclide therapy, Illuccix has the potential to improve treatment outcomes and quality of life for men with metastatic prostate cancer. Kevin Richardson, CEO of Telix Precision Medicine, stated that the Health Canada's decision will further improve access to advanced prostate cancer imaging and provide doctors with critical information to help make treatment decisions with confidence.
