The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 12 February 2025, approved gozetotide (brand name
Illuccix) to be used in a type of medical imaging procedure
called a Position Emission Tomography (PET) scan which is used to
detect specific types of cancer cells in adults with prostate
cancer.
Gozetotide binds to the cancer cells with prostate-specific
membrane antigen (PSMA) on their surface, making them visible
during the PET scan.
This gives healthcare professionals valuable information about
the disease to help inform treatment options.
The pharmaceutical form of this medicine is administered as one
solution for injection.
Beach, MHRA Interim Executive
Director of Healthcare Quality and Access, said:
“Patient safety is our top priority, which is why I am pleased to
confirm approval of gozetotide to detect specific types of cancer
cells in adults with prostate cancer.
“We're assured that the appropriate regulatory standards of
safety, quality and effectiveness for the approval of this new
formulation have been met.
“As with all products, we will keep its safety under close
review.”
A number of pivotal and supportive studies from the literature
were presented to demonstrate efficacy and safety in the proposed
indication, which are summarised in the Summary of Product
Characteristics (SmPC).
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Some of the potential side effects include a temporarily
increased blood level of a digestive enzyme (amylase),
constipation, feeling weak, and warmth where the injection site
is given.
For the full list of all side effects reported with this
medicine, see Section 4 of the Patient Information Leaflet (PIL)
or the SmPC available on the MHRA website.
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 MHRA 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 12 February
2025 to TELIX PHARMACEUTICALS (UK) LIMITED
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This product was submitted and approved via a national
procedure.
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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.
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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.
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The MHRA is an executive agency of the Department of Health
and Social Care.
