FDA Granted RMAT Designation Based on ALPHA3 Trial Futility Analysis, Highlighting Cema-Cel's Potential to Transform Disease Treatment in First-Line LBCL Consolidation Cema-Cel Induced Rapid and Substantial MRD Clearance of 58.3%, with a 97.7% Median Decrease in Plasma ctDNA at Day 45, Compared With a 26.6% Median Increase in the Observation Arm Cema-Cel Was Well-Tolerated, With Most Patients Managed in the Outpatient Setting and No Hospitalizations for Treatment-Related Adverse Events FDA Also Granted Fast Track Designation to Cema-Cel for the ALPHA3 Development Program RMAT and Fast Track Status Enable Enhanced FDA Engagement and Support Potential Expedited Development and Review Pathways SOUTH SAN FRANCISCO, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- 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).
