Jemperli
dostarlimab
Table of contents
Overview
Jemperli is a cancer medicine for treating certain types of endometrial cancer (cancer of the womb) that are advanced or have come back and have got worse despite treatment involving a platinum-based cancer medicine.
Jemperli is for endometrial cancer where the cancer cells have genetic abnormalities (called mismatch repair deficiency and high microsatellite instability) which prevent them from correcting mistakes that occur during cell division.
Jemperli contains the active substance dostarlimab.
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Jemperli : EPAR - Medicine overview (PDF/126.06 KB)
First published: 03/05/2021
EMA/134553/2021 -
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Jemperli : EPAR - Risk-management-plan summary (PDF/451.51 KB)
First published: 03/05/2021
Last updated: 19/04/2023
Authorisation details
Product details | |
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Name |
Jemperli
|
Agency product number |
EMEA/H/C/005204
|
Active substance |
dostarlimab
|
International non-proprietary name (INN) or common name |
dostarlimab
|
Therapeutic area (MeSH) |
Endometrial Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01FF07
|
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 |
GlaxoSmithKline (Ireland) Limited
|
Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
21/04/2021
|
Contact address |
12 Riverwalk |
Product information
15/12/2022 Jemperli - EMEA/H/C/005204 - 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 and Antibody Drug Conjugates
Therapeutic indication
Jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.