belantamab mafodotin

This medicine is authorised for use in the European Union.


Blenrep is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is given to adults who have received at least four previous treatments and whose disease does not respond to treatment with at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody (types of cancer medicines), and whose cancer has worsened since receiving the last treatment.

Multiple myeloma is rare, and Blenrep was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 October 2017.

Blenrep contains the active substance belantamab mafodotin.

This EPAR was last updated on 31/03/2023

Authorisation details

Product details
Agency product number
Active substance
belantamab mafodotin
International non-proprietary name (INN) or common name
belantamab mafodotin
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
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.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
GlaxoSmithKline (Ireland) Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24

Product information

30/03/2023 Blenrep - EMEA/H/C/004935 - IB/0018

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Product information documents contain:

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

Blenrep is indicated as monotherapy 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 one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Assessment history

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