Posted by Michael Wonder on 03 Feb 2020
GSK announces EMA accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma
3 February 2020 - Belantamab mafodotin accepted for accelerated assessment by the EMA’s CHMP.
GlaxoSmithKline today announced that the EMA validated the marketing authorisation application for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
The application is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study.
