Thursday, January 23, 2020
FDA Grants Priority Review of Belantamab Mafodotin for R/R Multiple Myeloma
The FDA granted a priority review for a Biologics License Application (BLA) seeking approval of belantamab mafodotin 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 (2019; https://doi.org/10.1016/S1470-2045(19)30788-0).
The study focused on the immunoconjugate targeting B-cell maturation antigen (BCMA) in a heavily pre-treated patient population who was refractory to an immunomodulatory drug and a proteasome inhibitor, and refractory or intolerant to an anti-CD38 antibody. Belantamab mafodotin has the potential to be the first anti-BCMA treatment available to patients.
In 2017, belantamab mafodotin was granted Breakthrough Therapy designation by the FDA, which is intended to facilitate the development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.
Belantamab mafodotin is an investigational immunoconjugate comprising a humanized anti-B cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker.
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines (Clin Cancer Res 2013;19(8):2048-60).