Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to cemacabtagene ansegedleucel (cema-cel) for the treatment of adult patients with large B-cell lymphoma (LBCL) who, at the completion of first-line (1L) therapy, are in complete or partial response suitable for observation but test positive for minimal residual disease (MRD). Together, the designations enable more frequent FDA engagement and support an efficient development and review process.

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