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FDA grants priority review to GSK 2857916 in relapsed or refractory multiple myeloma.- GlaxoSmithKline

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Published:22nd Jan 2020
GlaxoSmithKline plc announced the FDA has granted a priority review for the company's Biologics License Application (BLA) seeking approval of GSK 2857916 (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.Comment: Belantamab mafodotin is an investigational immunoconjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa. See- "Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study" Sagar Lonial et al. Lancet Oncology December 16, 2019 online first DOI:
Condition: Multiple Myeloma
Type: drug

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