Medical imaging agent gozetotide approved for diagnosis of prostate cancer
Source: gov.uk (2025-02-12)

Gozetotide binds to the cancer cells with prostate-specific membrane antigen (PSMA) on their surface, making them visible during the PET scan.

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.

Julian 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/ (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fyellowcard.mhra.gov.uk%2F&data=05%7C02%7CCharles.haddon%40mhra.gov.uk%7C493da54ae6bf4d1e1ee208dd4b7ff0a4%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C638749735058195796%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Jw1Mk0ovWpjYGN0g%2FAOkmX9iaSIUHjXdX9iBxHf1jlY%3D&reserved=0)) 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

This product was submitted and approved via a national procedure.

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://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fproducts.mhra.gov.uk%2F&data=05%7C02%7CCharles.haddon%40mhra.gov.uk%7C493da54ae6bf4d1e1ee208dd4b7ff0a4%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C638749735058218619%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=7evvDqSOqQHqOP2%2BUxekNNyHRD8AX%2F%2FxUs3MSlaOXL4%3D&reserved=0) within 7 days of approval.

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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