Belantamab Mafodotin Granted Priority Review by FDA for Resistant Multiple Myeloma
Posted: Tuesday, January 28, 2020
On January 21, GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) granted Priority Review for its biologics license application seeking approval of belantamab mafodotin (GSK2857916) in 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. Granted Breakthrough Therapy designation in 2017, this immunoconjugate targeting the B-cell maturation antigen (BCMA) is the focus of the DREAMM-2 clinical trial.
The DREAMM-2 study enrolled 293 heavily pretreated patients who had actively progressing multiple myeloma that had worsened despite current treatment, and 196 were included in the intention-to-treat population. In the study, recently published in The Lancet Oncology, single-agent belantamab mafodotin showed “antimyeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma.”
