TGA approves superior PSMA-PET imaging to inform prostate cancer management

MedTech News: Australian Therapeutic Goods Administration (TGA) has approved prostate-specific membrane antigen positron emission tomography (PSMA-PET) for informing treatment of patients with
prostate cancer.

Illuccix, after radiolabeling with gallium-68, is the first GMP manufactured PSMA-PET imaging agent commercially approved and 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.”

The results from the ProPSMA trial have shown that men with high-risk prostate cancer get more accurate results from PSMA-PET scans at diagnosis. They can forgo the CT and bone scans, reducing their radiation exposure. Having the higher accuracy PSMA-PET scans changed treatment plans in 28% of cases and lead to fewer ambiguous results.

The company told Health Industry Hub that prior to the TGA approval, PSMA-PET was only available under Special Access Scheme (SAS). Telix’s product can be produced by cyclotron, but importantly it can also be produced by a generator which gives greater flexibility for patients and the ability to access it within imaging centres right across Australia.

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.”

The Medical Services Advisory Committee (MSAC) has recommended the creation of new Medicare Benefits Schedule (MBS) items for PSMA-PET for informing treatment of patients with prostate cancer. MSAC also advised that PSMA PET/CT had acceptable cost-effectiveness and financial impact. Once this recommendation is adopted, it is expected that some of the cost of PSMA-PET will be covered by Medicare.

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 (primary staging), and
2. Patients with prostate cancer who have suspected recurrence based on elevated serum prostate specific antigen (PSA) level (biochemical recurrence).