GlaxoSmithKline (GSK) has secured US approval for Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, GSK said.
To date, Blenrep is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere in the world.
Blenrep is GSK’s fifth major medicine approval in 2020 across areas of significant unmet medical need such as cancer, HIV and chronic kidney disease.
This approval marks the second FDA approval for GSK’s oncology portfolio in four months.