FDA Grants BCMA Antibody-Drug Conjugate Breakthrough Status for Myeloma

November 2, 2017 – The FDA has granted GSK2857916 a breakthrough therapy designation for patients with relapsed/refractory multiple myeloma, according to GlaxoSmithKline (GSK), the manufacturer of the B-cell maturation antigen (BCMA) antibody-drug conjugate. GSK2857916 is indicated for patients who have failed at least 3 prior lines of therapy, including an anti-CD38 antibody, and are refractory to a proteasome inhibitor and an immunomodulatory … (leggi tutto)