Posted by Michael Wonder on 21 Jan 2020
US FDA grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma
21 January 2020 - Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients.
GlaxoSmithKline announced the US FDA granted a priority review for the company’s Biologics License Application (BLA) seeking approval of belantamab mafodotin (GSK2857916) 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 BLA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, recently published in The Lancet Oncology, which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.
