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).
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 within 7 days of approval.
-
For more information about prostate cancer, visit: www.nhs.uk/conditions/prostate-cancer/
