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GSK’s drug accepted for accelerated assessment by the EMA

LONDON: GlaxoSmithKline pharmaceutical company recently announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for belantamab mafodotin. The drug could be used 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. Belantamab mafodotin was accepted for accelerated assessment by the EMA’s Committee for Human Medicinal Products (CHMP).

A recent Press Release stated that accelerated assessment was granted if the CHMP determines the treatment was of major interest from a public health perspective and represents a therapeutic innovation. Validation of the MAA confirmed that the submission was accepted and began the formal review process by the CHMP.

The MAA was based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study. Full results from the study, recently 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.

More than 48,000 people in the European Union were diagnosed with multiple myeloma in 2018. Belantamab mafodotin was granted PRIME designation in 2017 by the EMA, a programme that was intended to facilitate development of investigational medicines that have shown clinical promise for conditions where there was significant unmet need.

-MN Report

February 4, 2020

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