US FDA approves Blenrep (belantamab mafodotin-blmf) for the treatment relapsed or refractory multiple myeloma

Approval is for use as monotherapy in adult patients who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent, and is based on six-month primary results from the pivotal DREAMM-2 study.

SPS commentary:

Belantamab employs a multi-faceted mechanism of action and is directed toward BCMA, a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells.

In the DREAMM-2 study (n=97), treatment with single-agent belantamab 2.5 mg/kg every three weeks demonstrated an overall response rate of 31% in patients who had received a median of seven prior lines of treatment

Last month, the European CHMP recommend approval of marketing authorisation for belantamab.


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