Blenrep, belantamab mafodotin: CHMP Positive Opininon
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 Blenrep, intended for the treatment of relapsed or refractory multiple myeloma.
Blenrep (belantamab mafodotin), developed by GlaxoSmithKline, is an antibody-drug conjugate targeting BCMA on myeloma cells, approved for treating relapsed or refractory multiple myeloma in combination with bortezomib and dexamethasone or pomalidomide and dexamethasone after at least one prior therapy. Clinical trials demonstrated that Blenrep prolongs progression-free survival, with common side effects including visual disturbances, thrombocytopenia, and neutropenia. The product holds orphan drug designation and was positively recommended by the CHMP as of May 22, 2025, with detailed usage guidelines forthcoming from the EMA.
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:
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in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
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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 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.