World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men
Source: gov.uk (2025-03-28)

As with all products, the MHRA will keep its safety under close review.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved trofolastat (RoTecPSMA), the first prostate-specific membrane antigen (PSMA)-targeting product authorised for use with technetium-99m to detect cancerous lesions in men with prostate cancer.

Prostate cancer is one of the most common cancers in men in the UK, with 1 in 8 men diagnosed in their lifetime. Diagnostic imaging plays an important role in identifying cancerous areas, which may help guide treatment decisions.

Trofolastat is combined with the radioactive tracer technetium-99m to form Technetium (99mTc) trofolastat, which is administered as a single injection. It binds to a protein called PSMA found on prostate cancer cells, helping doctors identify cancerous areas during a medical imaging technique known as single photon emission computed tomography (SPECT).

Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:

Keeping patients safe and ensuring access to high quality, safe and effective medical products are key priorities for the MHRA.

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.

The approval of this diagnostic product follows a rigorous assessment to ensure that it meets the required regulatory standards. As with all products, we will continue to monitor its safety and effectiveness.

Trofolastat has been approved for use in three clinical settings: identifying how far high-risk prostate cancer has spread before treatment, detecting recurrence in patients with rising prostate-specific antigen (PSA) levels, and determining whether targeted therapies might be effective for metastatic prostate cancer patients.

This national approval is supported by evidence from a multi-centre, prospective study involving 105 prostate cancer patients. Technetium (99mTc) trofolastat demonstrated 94.2% sensitivity in identifying prostate cancer lesions and an 83.3% specificity in confirming cancer-free areas.

The most common side effect associated with Technetium (99mTc) trofolastat was headache. A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.

As with any medicine, the MHRA will keep the safety and effectiveness of RoTecPSMA under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

ENDS

Notes to editors

The new marketing authorisation was granted on 27th March 2025.

More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website (https://products.mhra.gov.uk/) within 7 days of approval.

For more information about prostate cancer, visit: www.nhs.uk/conditions/prostate-cancer/ (https://www.nhs.uk/conditions/prostate-cancer/)

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

The MHRA is an executive agency of the Department of Health and Social Care.

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