In August 2020, the FDA accelerated the approval of Blenrep (belantamab mafodotin-blmf; from GlaxoSmithKline), a BCMA-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with relapsed or refractory multiple myeloma who have received 4 or more previous therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory drug. Blenrep is the first BCMA antibody, representing a new approach to the treatment of multiple myeloma.
The FDA approved Blenrep based on an open-label, multicenter clinical trial in which patients received Blenrep therapy by intravenous infusion once every 3 weeks, until their disease progressed or if they had unacceptable side effects.
The efficacy of Blenrep was established based on the overall response rate to treatment and the duration of the response. The overall response rate was 31%, and 73% of those who had a response to therapy with Blenrep had a response lasting 6 months or longer.
The most common side effects associated with Blenrep therapy included keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.
Blenrep is associated with a risk for serious vision-related side effects.