Blenrep

Withdrawn

This medicine's authorisation has been withdrawn

belantamab mafodotin

Overview

The conditional marketing authorisation for Blenrep has not been renewed by the European Commission.

Blenrep : EPAR - Medicine overview

Reference Number: EMA/407643/2020

Blenrep : EPAR - Risk Management Plan

Product information

Blenrep : EPAR - Product information

Latest procedure affecting product information: R/017

23/02/2024

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).

Blenrep : EPAR - All authorised presentations

Product details

• Name of medicine:
  Blenrep
• Active substance:
  belantamab mafodotin
• International non-proprietary name (INN) or common name:
  belantamab mafodotin
• Therapeutic area (MeSH):
  Multiple Myeloma
• Anatomical therapeutic chemical (ATC) code:
  L01XC39

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004935
• 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.

• Orphan:

  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.

• Marketing authorisation holder:
  GlaxoSmithKline (Ireland) Limited

  12 Riverwalk; Citywest Business Campus; Dublin 24; Ireland

• Opinion adopted:
  23/07/2020
• Marketing authorisation issued:
  25/08/2020
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Blenrep : EPAR - Procedural steps taken and scientific information after the authorisation

Blenrep-H-C-004935-R-0017 : EPAR - Assessment Report - Renewal

Reference Number: EMA/72045/2024

Blenrep-H-C-PSUSA-00010869-202208 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/264790/2023

Initial marketing authorisation documents

Blenrep : Orphan maintenance assessment report (initial authorisation)

AdoptedReference Number: EMADOC-1700519818-499024

Blenrep : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/414341/2020 Corr.

CHMP summary of positive opinion for Blenrep

AdoptedReference Number: EMA/383350/2020