Locametz
Authorised
This medicine is authorised for use in the European Union
gozetotide
Medicine
Human
Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Locametz is a diagnostic medicine used in adults with prostate cancer to detect prostate cancer cells with a protein called prostate‑specific membrane antigen (PSMA) using the body scan known as positron-emission tomography (PET).
It is used:
- to find out whether prostate cancer has spread to lymph nodes and other tissues outside the prostate before curative treatment is started;
- to find out whether prostate cancer has returned in patients whose blood levels of prostate specific antigen (PSA) are increasing after previous curative treatment;
- to find out whether patients have PSMA-positive progressive metastatic castration-resistant prostate cancer, which may be suitable for a specific therapy called PSMA-targeted therapy. Metastatic castration-resistant prostate cancer is cancer that has spread to other parts of the body despite treatment to lower testosterone levels, including surgical removal of the testes.
Before use, the medicine is coupled (radiolabelled) with a radioactive substance called gallium (68Ga) so that it can carry radioactivity to the site of the cancer cells and allow detection of these cells using PET.
Locametz contains the active substance gozetotide.
The medicine can only be given in a designated nuclear medicine facility by trained healthcare professionals with technical expertise in using and handling nuclear medicine imaging agents.
Locametz is never given to a patient on its own. Before it is given it must be radiolabelled with gallium (68Ga). The radiolabelled Locametz is then given as a slow injection into a vein at a dose depending on the patient’s weight, and a PET scan is done after the injection.
For more information about using Locametz, see the package leaflet or contact your doctor or pharmacist.
The active substance of Locametz, gozetotide, binds to PSMA, which is found in large numbers on the surface of most prostate cancer cells. When Locametz is radiolabelled with gallium (68Ga) and given to a patient, it binds to PSMA and is taken up by the cells and gives off radiation, which can be detected with a PET scan. This allows the doctors to see where in the body the cancer cells are.
Several published studies have supported the usefulness of gozetotide that has been radiolabelled with gallium (68Ga) as a sensitive and accurate diagnostic medicine to detect if prostate cancer has returned or spread or if cancer cells contain PSMA.
The most common side effects with gallium (68Ga)-radiolabelled Locametz are tiredness (which may affect up to 1 in 10 people), nausea (feeling sick), constipation and vomiting (which may affect up to 1 in 100 people).
For the full list of side effects and restrictions with Locametz, see the package leaflet.
The European Medicines Agency considered that the use of gallium (68Ga)-radiolabelled Locametz was well documented in the scientific literature, with data suggesting that gallium (68Ga)-radiolabelled Locametz may offer improvements over existing methods for detecting prostate cancer that has not yet been treated or has returned, or for screening patients who may benefit from PSMA-targeted treatment. Locametz’s side effects were usually mild and its safety profile was considered acceptable. The Agency therefore decided that Locametz’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Locametz will provide medical practitioners who are expected to use gallium (68Ga)-radiolabelled Locametz with educational materials to support interpretation of PET scans.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Locametz have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Locametz are continuously monitored. Suspected side effects reported with Locametz are carefully evaluated and any necessary action taken to protect patients.
Locametz received a marketing authorisation valid throughout the EU on 09 December 2022.
Product information
Latest procedure affecting product information:N/0000261049
31/03/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Locametz
- Active substance
- gozetotide
- International non-proprietary name (INN) or common name
- gozetotide
- Therapeutic area (MeSH)
- Radionuclide Imaging
- Anatomical therapeutic chemical (ATC) code
- V09I
Pharmacotherapeutic group
Diagnostic radiopharmaceuticalsTherapeutic indication
This medicinal product is for diagnostic use only. Locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:
- Primary staging of patients with high risk PCa prior to primary curative therapy,
- Suspected PCa recurrence in patients with increasing levels of serum prostate specific antigen (PSA) after primary curative therapy,
- Identification of patients with PSMA positive progressive metastatic castration resistant prostate cancer (mCRPC) for whom PSMA targeted therapy is indicated (see section 4.4).
News on Locametz
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