Nexpovio

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selinexor

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

Overview

Nexpovio is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is used together with another medicine, dexamethasone, in adults who have received at least four previous treatments and whose disease has worsened since the last treatment.

Nexpovio contains the active substance selinexor.

This EPAR was last updated on 07/06/2021

Authorisation details

Product details
Name
Nexpovio
Agency product number
EMEA/H/C/005127
Active substance
Selinexor
International non-proprietary name (INN) or common name
selinexor
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XX66
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
Karyopharm Europe GmbH
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address

Franziska-Bilek-Weg 9
80339
Munich
Germany

Product information

26/03/2021 Nexpovio - EMEA/H/C/005127 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Nexpovio is indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Assessment history

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