Telix has announced that the TGA has approved the use of Illuccix to select patients for PSMA-targeted radionuclide therapy.
Illuccix remains the only PSMA-PET agent approved in Australia and listed on the Medicare Benefits Schedule for imaging prostate cancer patients.
Telix said the label expansion means Illuccix is now approved to select patients with metastatic prostate cancer for treatment with the only approved PSMA-targeted radionuclide therapy.
The latest approval expands the clinical utility for Illuccix, which has been approved in Australia since November 2021 for the initial staging of intermediate to high-risk patients with prostate cancer and the re-staging of patients with recurrent prostate cancer.
Anne Savage, CEO of Prostate Cancer Foundation of Australia, commented, “Prostate cancer is the most commonly diagnosed cancer in Australia, with an estimated 26,368 men likely to be diagnosed in 2024. Of concern, around 4,000 of these newly diagnosed men will have Stage III or IV metastatic prostate cancer, which has spread beyond the prostate to other parts of the body, becoming more immediately life-threatening. Reflecting Telix’s continued innovation and commitment to patient care, this additional approved indication for Illuccix will help fulfil a critical unmet need by facilitating access to timely and effective treatment with PSMA-targeted therapy.”
Raphaël Ortiz, CEO of Telix International, added, “We welcome the TGA’s decision to approve Illuccix for selecting patients for PSMA-targeted therapy. Historically, many radiopharmaceuticals in Australia – including PSMA theranostics – have been produced in-house not subject to regulatory approval or GMP standards. With Illuccix now registered on the ARTG for broader use, widely available and reimbursed, Telix is actively working with clinical sites to ensure patients have access to the only approved PSMA-PET imaging agent in Australia.
“Men with prostate cancer deserve to be given products that have been through clinical trials and are subject to rigorous evaluation by regulatory authorities for quality, effectiveness, and safety profile. By accurately identifying patients most likely to respond to therapy, Illuccix has the potential to reduce the mortality burden of prostate cancer in Australia – a burden which claims the lives of 3,743 men every year.”