Jemperli

RSS

dostarlimab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 16/07/2021

Authorisation details

Product details
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
L01XC40
Additional monitoringAdditional 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 approvalConditional 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
Marketing-authorisation holder
GlaxoSmithKline (Ireland) Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
21/04/2021
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

01/07/2021 Jemperli - EMEA/H/C/005204 - IB/0002

Contents

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Pharmacotherapeutic group

Antineoplastic agents

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.

Assessment history

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