Allogene Therapeutics IncFDA granted RMAT and Fast Track designations for cema-cel, accelerating development and review.

Allogene Therapeutics announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy and Fast Track designations to its investigational CAR-T therapy cemacabtagene ansegedleucel, or cema-cel, for high-risk large B-cell lymphoma. The designations apply to adult patients with large B-cell lymphoma who are in complete or partial response after first-line therapy, are suitable for observation, but test positive for minimal residual disease. The decision was supported by interim data from the ongoing Phase 2 ALPHA 3 trial, in which cema-cel achieved a minimal residual disease clearance rate of 58.3% compared with 16.7% in the observation arm, and a median decrease in plasma circulating tumor DNA at Day 45 of 97.7% versus a 26.6% median increase in the observation arm. The therapy was well-tolerated, with most patients treated in the outpatient setting and no treatment-related hospitalizations reported. Allogene shares closed Thursday up 9.04% at $1.81 and rose a further 0.55% in overnight trading to $1.82.
Allogene Therapeutics IncFDA granted RMAT and Fast Track designations for cema-cel, accelerating development and review.