Approvals

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Telix Pharmaceuticals’ imaging agent Illuccix (gozetotide) for use in adult prostate cancer patients who are undergoing a position emission tomography (PET) scan.

Illuccix is administered as an injection and is designed to bind to cancer cells with prostate-specific membrane antigen (PSMA) on their surface, making them visible during a PET scan.

Approximately 55,100 new cases of prostate cancer are diagnosed in the UK every year. According to Telix, PSMA-PET imaging represents a “major advancement” in prostate cancer management and largely replaces conventional imaging methods as the standard of care after initial diagnosis and biochemical recurrence.

The MHRA’s decision on Illuccix, which will be made available in the UK through Telix’s exclusive distribution partner Xiel, was based on “a number of pivotal and supportive studies” demonstrating the agent’s efficacy and safety in this indication, the regulator outlined.

Raphaël Ortiz, chief executive officer of Telix International, said: “PSMA-PET imaging is one of the most important developments in prostate cancer detection in recent years and we are delighted that we can now bring Illuccix to physicians and their patients across the UK.”

Also commenting on the approval, Gary Cook, professor of molecular imaging at Kings College London School of Biomedical Engineering and Imaging Sciences, said: “PSMA-PET supply shortages in the UK and Europe have escalated over the past 12 months as demand increases… It is great news that Telix can now help address this unmet need and improve equity of access in the UK through [its] Illuccix imaging agent and network distribution model.”