FDA Grants Fast Track Designation to ‘Off-the-shelf’ CAR T-cell Therapy

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FDA Grants Fast Track Designation to ‘Off-the-shelf’ CAR T-cell Therapy
September 22, 2020September 22, 2020
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The U.S. Food and Drug Administration has granted fast track designation to PBCAR269A, Precision BioSciences‘ donor-derived CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. Fast track status is meant to facilitate the development, and accelerate the review, of new medications that aim to treat serious conditions and fill an unmet medical need. Medications given this designation are eligible for a series of benefits, including the potential for accelerated approval and priority review. This designation…

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