Locametz
gozetotide
Table of contents
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.
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Locametz: EPAR - Medicine overview (PDF/142.86 KB)
First published: 21/12/2022 -
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Locametz: EPAR - Risk-management-plan (PDF/1.11 MB)
First published: 21/12/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Locametz
|
| Agency product number |
EMEA/H/C/005488
|
| Active substance |
gozetotide
|
| International non-proprietary name (INN) or common name |
gozetotide
|
| Therapeutic area (MeSH) |
Radionuclide Imaging
|
| Anatomical therapeutic chemical (ATC) code |
V09I
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Novartis Europharm Limited
|
| Revision |
1
|
| Date of issue of marketing authorisation valid throughout the European Union |
09/12/2022
|
| Contact address |
Vista Building |
Product information
30/01/2023 Locametz - EMEA/H/C/005488 - N/0001
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Diagnostic radiopharmaceuticals
Therapeutic 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).