GlaxoSmithKline has announced that the European Medicines Agency (EMA) has validated its marketing authorisation application (MAA) for belantamab mafodotin.
The drug, which is 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, was also accepted for accelerated assessment by the EMA’s Committee for Human Medicinal Products (CHMP).
Accelerated assessment is a status granted if the CHMP determines the treatment is of major interest from a public health perspective, and represents a “therapeutic innovation.”
The organisation says that the MAA is based on data from the pivotal DREAMM-2 study, in which the drug demonstrated a 31% overall response rate (ORR), and safety and tolerability profiles consistent with previously reported data on belantamab mafodotin.
The treatment was also granted PRIME designation in 2017 by the EMA, a programme that is intended to facilitate development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.
More than 48,000 people in the European Union were diagnosed with multiple myeloma in 2018. It is the second most common blood cancer and is generally considered treatable, but not curable.
