Blenrep

Expired

This medicine's authorisation has expired

belantamab mafodotin

Overview

On 23 February 2024, the European Commission issued a decision to not renew the conditional marketing authorisation for Blenrep (belantamab mafodotin) in the European Union (EU). The marketing authorisation holder for the medicine was GlaxoSmithKline (Ireland) Limited. 

The non-renewal of the marketing authorisation follows the opinion issued by EMA’s human medicines committee, CHMP, which recommended to not renew the authorisation because the benefits of Blenrep no longer outweigh its risks. 

Further information is available in the news announcement published at the time of the CHMP opinion. 

Blenrep was granted a conditional marketing authorisation valid throughout the EU on 25 August 2020 for the treatment of multiple myeloma. 

The European Public Assessment Report (EPAR) for Blenrep has been updated to indicate that the marketing authorisation is no longer valid.

Blenrep : EPAR - Medicine overview

Reference Number: EMA/407643/2020

Blenrep : EPAR - Risk Management Plan

Product information

Blenrep : EPAR - Product information

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.

• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• 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
• Expiry of marketing authorisation:
  23/02/2024
• 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