GSK’s Blenrep Wins BCMA Race, Carries Ocular Toxicity Warning

US FDA-approved belantamab mafodotin is indicated for heavily pre-treated multiple myeloma and has a list price of $23,900 per month. Its REMS could limit initial uptake, but response rates have been encouraging.

Doctor using stethoscope on Multiple myeloma and medicine background. Futuristic technology. data hologram healthy
Belantamab mafodotin is indicated for myeloma after four prior lines of therapy • Source: Shutterstock

GlaxoSmithKline plc won the first-ever US Food and Drug Administration approval for a therapeutic targeting B-cell maturation antigen (BCMA) on 5 August and plans to make Blenrep (belantamab mafodotin) available before the end of the month. The antibody-drug conjugate (ADC) is indicated for the treatment of relapsed or refractory multiple myeloma after at least four prior rounds of treatment, including an immunomodulatory drug, proteasome inhibitor and an anti-CD38 antibody.

The FDA approval of the first-in-class drug caps a development-acceleration plan for the drug put in place by CEO Emma Walmsley when she took over the leadership of GSK in 2017, emphasizing pharmaceutical innovation and a return to oncology

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