EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Blenrep (belantamab mafodotin) to treat adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody.

Multiple myeloma is a cancer of a type of white blood cell called plasma cells that is responsible for about 2% of all cancer deaths. Normal plasma cells are found in the bone marrow and are an important part of the immune system. Plasma cells make the antibodies that enable the body to recognise and attack germs such as viruses or bacteria. They originate from B-cell lymphocytes and form when B-cells respond to an infection. When plasma cells become cancerous, they no longer protect the body from infections and produce abnormal proteins that can cause problems affecting the kidneys, bones or blood.

A range of new medicines for the treatment of multiple myeloma have been developed and approved in recent years, leading to a steady overall improvement in survival of patients. However, for patients who have already been treated with three major classes of drugs (immunomodulatory agents, proteasome inhibitors and monoclonal antibodies) and no longer respond to these drugs, the outlook is still bleak. There is an unmet medical need for new treatments that improve survival of these patients beyond the currently observed three months or less.

Blenrep was accepted in EMA’s PRIME scheme and has benefited from the extra support offered by the Agency to medicines that have a particular potential to address patients’ unmet medical needs. Blenrep has a new mechanism of action that targets B-cell maturation antigen (BCMA), a protein that is present on the surface of virtually all multiple myeloma cells. BCMA is absent from normal B-cells, making it an ideal drug target.

Structurally, Blenrep is an antibody-drug conjugate that combines a monoclonal antibody with maleimidocaproyl monomethyl auristatin F (mcMMAF), which is a cytotoxic agent. The medicine binds to BCMA on myeloma cell surfaces and once inside the myeloma cell, the cytotoxic agent is released leading to apoptosis, the ‘programmed’ death of the cancerous plasma cells.

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