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.”
