Gavreto
pralsetinib
Table of contents
Overview
Gavreto is a cancer medicine for treating adults with advanced non-small cell lung cancer caused by changes in a gene called RET (known as RET fusion-positive NSCLC) and who have not been treated with a RET inhibitor.
Gavreto contains the active substance pralsetinib.
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Gavreto : EPAR - Medicine Overview (PDF/99.11 KB)
First published: 09/12/2021
EMA/576914/2021 -
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Gavreto : EPAR - Risk management plan summary (PDF/159.68 KB)
First published: 09/12/2021
Last updated: 24/03/2022
Authorisation details
Product details | |
---|---|
Name |
Gavreto
|
Agency product number |
EMEA/H/C/005413
|
Active substance |
pralsetinib
|
International non-proprietary name (INN) or common name |
pralsetinib
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
|
Anatomical therapeutic chemical (ATC) code |
L01XE
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
18/11/2021
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
20/07/2023 Gavreto - EMEA/H/C/005413 - II/0013
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
Antineoplastic agents
Therapeutic indication
Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.