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GSK Files Its BCMA Drug In Multiple Myeloma

Filing Underpinned By Good DREAMM-2 results

 
• By Sten Stovall

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.

Multiple_Myeloma
GSK’s Could Become First Anti-BCMA Agent Approved In US • Source: Shutterstock

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 on 16 December said full results from its DREAMM-2, published in The Lancet Oncology, were consistent with those seen in a similar subset of patients in the DREAMM-1 study, a Phase I/II in heavily pre-treated patients

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