Australian TGA Approves Illuccix® for Prostate Cancer Imaging

Melbourne (Australia) – 02 November 2021. Australian Therapeutic Goods Administration has approved Illuccix® for the diagnostic imaging of men with prostate cancer.

Telix is delighted to announce that the Australian Therapeutic Goods Administration (TGA) has approved Illuccix® (Kit for the preparation of 68Ga PSMA-11 Injection) is a positron emission tomography (PET) agent for the diagnostic imaging of men with prostate cancer. The TGA has granted Illuccix a broad clinical indication comprising:

  1. Patients with prostate cancer who are at risk of metastasis and who are suitable for initial definitive therapy (also known as “primary staging”), and
  2. Patients with prostate cancer who have suspected recurrence based on elevated serum prostate specific antigen (PSA) level (also known as “biochemical recurrence”).

Illuccix®, after radiolabeling with gallium-68, is the first commercially approved PSMA-PET imaging agent available in Australia. The TGA approval of Illuccix facilitates wide-spread clinical access to prostate cancer imaging for all men across Australia including rural and regional areas, enabling availability of state-of-the-art PSMA PET imaging across the country.

Telix President APAC Dr. David Cade stated, “The approval of Illuccix means Australian patients with prostate cancer will have broad access to a TGA-approved PSMA-PET imaging agent. This new mode of imaging has been recognised in leading clinical practice guidelines as superior to conventional imaging with CT or MRI, for the staging of prostate cancer. Illuccix attaches to prostate cancer cells expressing PSMA and can be picked up by a PET scanner, giving physicians the ability to visualise tumour cells, including very small metastases, wherever they are in the body.”

Telix CEO Dr. Christian Behrenbruch added, “PSMA-PET imaging has been one of the most important developments in prostate cancer management in recent years. As an Australian company, we are especially pleased to be delivering the first TGA-approved, GMP manufactured PSMA-PET imaging agent that will be widely available to Australian patients. The TGA is a sophisticated regulatory authority that is highly regarded in the Asia Pacific region. This approval is an important milestone for Telix, demonstrating the approvability of Illuccix and establishing a blueprint for a series of near-term regulatory submissions and reviews in other important markets across the Asia Pacific.”

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