MHRA Grants World-First Approval for Trofolastat in Prostate Cancer Imaging

Introduction

The UK has become the first country in the world to approve Trofolastat, a PSMA-targeted radiopharmaceutical designed to support imaging of prostate cancer in men. The decision, announced by the MHRA, marks a regulatory milestone in the global use of diagnostic tools for this common cancer.

Use and Indication

Trofolastat is authorised to support diagnostic imaging in men with prostate cancer who are at risk of recurrence, or for whom initial therapy is being planned. The imaging will be carried out using positron emission tomography (PET) technology.

Clinical Significance

The approval is based on evidence showing that Trofolastat helps identify the extent and location of prostate cancer. This diagnostic tool is expected to enhance clinical decision-making and improve patient management.

Regulatory Perspective

Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, stated that this approval demonstrates the UK’s commitment to supporting innovation and improving patient outcomes. He highlighted the significance of being the first regulator in the world to approve Trofolastat.

Conclusion

This authorisation represents a key step forward in the early and accurate diagnosis of prostate cancer. The MHRA’s approval ensures that UK patients can benefit from cutting-edge diagnostic imaging to guide their care.

Citation:
UK Government. (2025, March 28). World-first as MHRA approves Trofolastat for diagnostic imaging of prostate cancer in men. GOV.UK