EMA provisionally approves first antibody-drug conjugate for multiple myeloma


  • Dawn O'Shea
  • Univadis Medical News
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The European Medicines Agency’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 CD38 monoclonal antibody.

A range of new medicines for the treatment of multiple myeloma have been developed and approved in recent years. But, for patients who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD38 monoclonal antibody, the outlook is still bleak.

Blenrep targets B-cell maturation antigen (BCMA) 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 the cytotoxic agent maleimidocaproyl monomethyl auristatin F (mcMMAF).

The main study on which the CHMP’s recommendation is based was a phase 2, open label, randomised, two-arm study investigating the efficacy and safety of two doses of belantamab mafodotin in patients whose disease was still active after ≥3 lines of therapy. The most common side effects were keratopathy and thrombocytopenia.