Blenrep

Opinion

EMA has issued an opinion on this medicine

belantamab mafodotin

Overview

On 22 May 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Blenrep¹, intended for the treatment of relapsed or refractory multiple myeloma.

The applicant for this medicinal product is GlaxoSmithKline Trading Services Limited.

Blenrep will be available as a 70 mg and 100 mg powder for concentrate for solution for infusion. The active substance of Blenrep is belantamab mafodotin, an antibody drug conjugate (ATC code: L01FX15). Belantamab mafodotin is made of a humanised IgG1κ monoclonal antibody targeting the B-cell maturation antigen (BCMA), conjugated with a cytotoxic agent, maleimidocaproyl monomethylauristatin F (mcMMAF). Belantamab mafodotin binds to BCMA on the surface of myeloma cells causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity.

The benefit of adding Blenrep to bortezomib and dexamethasone or pomalidomide and dexamethasone is a prolonged progression-free survival in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, as shown in two phase 3 randomised open-label studies. The most common side effects with Blenrep include reduced visual acuity, corneal examination findings (including keratopathy), thrombocytopenia, blurred vision, dry eye, foreign body sensation in eyes, eye pain, photophobia, eye irritation, neutropenia, anaemia and diarrhoea.

The full indication is:

Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma:

• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
• in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.

Treatment with Blenrep should be prescribed by physicians experienced in the treatment of multiple myeloma.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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¹This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

CHMP summary of positive opinion for Blenrep

AdoptedReference Number: EMA/CHMP/152727/2025

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:
  L01FX15
• EMA product number:
  EMEA/H/C/006511
• 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 applicant:
  GlaxoSmithKline Trading Services Limited
• Opinion adopted:
  22/05/2025
• Opinion status:
  Positive