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FDA Grants BCMA CAR T-Cell Therapy Breakthrough Designation in Myeloma

Jason Harris
Published: Thursday, Nov 16, 2017

The FDA has granted bb2121 a breakthrough therapy designation for previously treated patients with relapsed/refractory multiple myeloma, according to Celgene Corporation and bluebird bio, the companies developing the anti–B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy.

"Receiving breakthrough therapy designation and PRIME eligibility for bb2121 further underscores the potential of this novel cellular immunotherapy approach to multiple myeloma treatment," Jay Backstrom, MD, chief medical officer and head of Global Regulatory Affairs for Celgene, said in a statement. "We will work closely with these agencies as we accelerate development of bb2121, a novel technology and therapy for patients with multiple myeloma."
Lin Y, Berdeja J, Raje N, et al. First-in-human multicenter study of bb2121 anti-BCMA CAR T cell therapy for relapsed/refractory multiple myeloma: updated results. Abstract presented at: 22nd Annual European Hematology Association Congress; June 22-25, 2017; Madrid, Spain. Abstract S142.

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