GlaxoSmithKline PLC has submitted a biologics license application to the US Food and Drug Administration for its anti-B-cell maturation antigen (BCMA) therapy, backed by detailed pivotal Phase II DREAMM-2 results showing the antibody-drug conjugate in late-stage multiple myeloma patients produced a good 31% response rate.
GSK Files Its BCMA Drug In Multiple Myeloma
Filing Underpinned By Good DREAMM-2 results
GSK has filed its anti-BCMA agent with the FDA after full Phase II DREAMM-2 data showed an overall response rate of 31% in patients with heavily pre-treated multiple myeloma.
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