Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
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.
Active Substances (1)
gozetotide
Documents (10)
CHMP summary of positive opinion for Locametz
October 14, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Locametz: EPAR - Risk-management-plan
December 21, 2022
RISK_MANAGEMENT_PLAN_SUMMARY
CHMP summary of positive opinion for Locametz
October 14, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Locametz: EPAR - Procedural steps taken and scientific information after authorisation (archive)
February 2, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Locametz: EPAR - Public assessment report
December 21, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Locametz: EPAR - Public assessment report
December 21, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Locametz: EPAR - All authorised presentations
December 21, 2022
AUTHORISED_PRESENTATIONS
Locametz: EPAR - Procedural steps taken and scientific information after authorisation
February 12, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Locametz: EPAR - Product information
December 21, 2022
DRUG_PRODUCT_INFORMATION
Locametz: EPAR - Medicine overview
December 21, 2022
OVERVIEW_DOCUMENT
Overview Q&A (7)
Question
How does Locametz work?
Answer
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.
Question
How is Locametz used?
Answer
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.
Question
What benefits of Locametz have been shown in studies?
Answer
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.
Question
What are the risks associated with Locametz?
Answer
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.
Question
Why is Locametz authorised in the EU?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of Locametz?
Answer
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.
Question
Other information about Locametz
Answer
Locametz received a marketing authorisation valid throughout the EU on 09 December 2022.