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FDA Grants CAR-T Therapy Breakthrough Therapy Designation


November 16, 2017

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to a chimeric antigen receptor T (CAR-T) drug for the treatment of patients with relapsed or refractory multiple myeloma.

The new CAR-T therapy, bb2121, was given the breakthrough designation based on preliminary data from an ongoing phase I trial (CRB-401). This therapy shows early promise for heavily pretreated patients with multiple myeloma. Updated data from CRB-401 will be presented at the 59th annual meeting of the American Society of Hematology (ASH) (December 11, 2017; Atlanta, GA).

“Receiving breakthrough therapy… for bb2121 further underscores the potential of this novel cellular immunotherapy approach to multiple myeloma treatment,” said Jay Backstrom, MDchief medical officer and head of Global Regulatory Affairs, Celgene, in a company-issued press release (November 16, 2017). “We will work closely with these agencies as we accelerate development of bb2121, a novel technology and therapy for patients with multiple myeloma.”

The new therapy also received Priority Medicines (PRIME) eligibility from the European Medicines Agency (EMA).

Zachary Bessette


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