Patients with relapsed or refractory multiple myeloma in Europe could have a new option after regulators accepted GlaxoSmithKline’s marketing authorisation application (MAA) for belantamab mafodotin.
Belantamab mafodotin was accepted for accelerated assessment by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP).
The MAA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study.
Full results from the study, published in The Lancet Oncology, demonstrated a 31% overall response rate (ORR) with a 2.5 mg/kg regimen of single-agent belantamab mafodotin in heavily pre-treated patients with multiple myeloma who were refractory to an immunomodulatory drug and a proteasome inhibitor and were refractory and/or intolerant to an anti-CD38 antibody.
The safety and tolerability profile was consistent with previously reported data on belantamab mafodotin.
Validation of the MAA confirms that the submission is accepted and begins the formal review process by the CHMP.