The TGA has approved Telix Pharmaceuticals' (ASX:TLX) lead prostate cancer imaging product, Illuccix (TLX591-CDx).
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 approved Illuccix for patients with prostate cancer who are at risk of metastasis and who are suitable for initial definitive therapy as well as those with prostate cancer who have suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Illuccix, after radiolabeling with gallium-68, is the first commercially approved PSMA-PET imaging agent available in Australia.
Telix's Dr David Cade said, “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 CT1 or MRI2, 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.”
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.”