The U.S. Food and Drug Administration (FDA) has awarded breakthrough therapy designations to 2 treatments, GSK2857961 and bb2121, that are currently being investigated as treatments for relapsed and refractory myeloma patients.
GSK2857961 is a B-cell maturation antigen (BCMA) targeted antibody, and data from a Phase I trial has shown that is has clinical efficacy in myeloma patients who have received 3 prior treatments including a CD38 antibody, and who are refractory to a proteasome inhibitor and an immunomodulatory drug. For more information, read the original article here.
bb2121 is a chimeric antigen receptor T-cell (CAR-T) therapy targeting BCMA. The decision to award bb2121 with a breakthrough therapy designation is based on preliminary results from the ongoing Phase I trial, CRB-401, which is investigating its use as a treatment for relapsed myeloma patients. These results will be presented at the American Society of Haematology annual meeting in December. Further information is available here.
Both drugs have also received PRIME designations from the European Medicines Agency (EMA). These designations will accelerate the development and review process in both the U.S. and Europe, with the aim of bringing GSK2857961, and bb2121 into clinical use for relapsed and refractory myeloma patients sooner.