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GSK gets breakthrough therapy designation from FDA

02 November 2017 07:44

GlaxoSmithKline's investigational BCMA antibody-drug conjugate has received breakthrough therapy designation from the US Food and Drug Administration for relapsed and refractory multiple myeloma.

GSK said the designation was received for GSK2857916 monotherapy in patients with multiple myeloma who had failed at least three prior lines of therapy, including an anti-CD38 antibody and were refractory to a proteasome inhibitor and an immunomodulatory agent.

In October, the European Medicines Agency granted PRIME designation to GSK2857916 for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.

GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate.

GSK2857916 has also received orphan drug designation from the EMA and FDA for multiple myeloma.

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