MHRA approves prostate cancer imaging agent trofolastat

Approximately 55,100 new cases of prostate cancer are diagnosed every year in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the prostate cancer imaging agent trofolastat (RoTecPSMA).

The regulator’s decision makes trofolastat the first prostate-specific membrane antigen (PSMA)-targeting product approved alongside the radioactive tracer technetium-99m to detect cancerous lesions in men with prostate cancer.

Approximately 55,100 new cases of prostate cancer are diagnosed every year in the UK, and diagnostic imaging plays a key role in the detection and management of the disease.

Technetium trofolastat, a combination of trofolastat and technetium-99m, is given to patients as a single injection and binds to the PSMA protein found on prostate cancer cells, helping doctors to identify cancerous areas.

The MHRA has approved trofolastat to identify how far high-risk prostate cancer has spread before treatment, to detect recurrence in patients with rising prostate-specific antigen levels, as well to determine whether targeted therapies might be effective for those with metastatic disease.

Its decision was based on evidence from a prospective study of 105 prostate cancer patients, in which technetium trofolastat demonstrated 94.2% sensitivity in identifying prostate cancer lesions and an 83.3% specificity in confirming cancer-free areas.

Julian Beach, MHRA interim executive director, healthcare quality and access, said: “As the first PSMA-targeting diagnostic product approved with technetium-99m, which is widely available in UK nuclear medicine facilities, this approval has the potential to expand access to prostate cancer imaging and support diagnostic pathways within the NHS.”