Allogene gets FDA Fast Track for ALLO-647; safety data from 87 patients at ASH

Allogene Therapeutics, Inc.

FDA granted Fast Track Designation for ALLO-647 in adult patients with r/r LBCL.
Safety review of 87 Phase 1 patients: no unexpected safety concerns, no GvHD or Grade ≥3 ICANS.
33 CAR T-naïve LBCL patients had 42% CR rate, median DOR 23.1 months.
EXPAND trial (N=70 r/r LBCL) enrolling in US/EU to support licensure of ALLO-647.
Grade ≥3 cytopenias decreased over time; rates consistent with autologous CAR T therapy.

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