Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Australian Therapeutic Goods Administration (TGA) has approved the use of Illuccix® (kit for the preparation of ⁶⁸Ga-PSMA-11^[1] injection) to select patients for PSMA^[2]-targeted radionuclide therapy.

Illuccix remains the only PSMA-PET^[3] agent approved in Australia, manufactured to GMP^[4] standards, and listed on the Medicare Benefits Schedule (MBS) for imaging patients with prostate cancer. This label expansion means that it is now approved to select patients with metastatic prostate cancer for treatment with the only approved PSMA-targeted radionuclide therapy (Lu 177 vipivotide tetraxetan, or Pluvicto®^[5]). To qualify for PSMA-targeted therapy, patients should be identified by PSMA imaging^[6].

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^[7]. 

Anne Savage, CEO 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."

Professor Andrew Scott AM, Director of the Department of Molecular Imaging and Therapy at Austin Health, Melbourne added, "In the VISION trial^[8], Telix's PSMA-PET agent was used to help doctors detect prostate cancer and identify appropriate patients for PSMA-targeted radionuclide therapy with Lu 177 vipivotide tetraxetan, based on a theranostic approach. It is great news for patients that Illuccix is now approved for this use in Australia, with clinicians able to use this product in more stages of the patient journey, to confidently and accurately detect and help manage this disease."

Raphaël Ortiz, CEO Telix International continued, "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^[9] 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."