Posted by Michael Wonder on 03 Nov 2017
GSK’s investigational BCMA antibody-drug conjugate receives breakthrough therapy designation from US FDA for relapsed and refractory multiple myeloma
2 November 2017 - GlaxoSmithKline today announced that it has received breakthrough therapy designation from the U.S. FDA for GSK2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent.
In October, the EMA 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.
