regulatory
confidence high
sentiment positive
materiality 0.75
Caribou Bio receives RMAT and Fast Track designations from FDA for CB-010 CAR-T therapy
Caribou Biosciences, Inc.
- FDA grants RMAT for relapsed/refractory large B cell lymphoma (LBCL) and Fast Track for r/r B-NHL for CB-010.
- CB-010 is first allogeneic anti-CD19 CAR-T with PD-1 knockout in clinic.
- In ANTLER Phase 1 trial at dose level 1: 6/6 patients (100%) achieved CR, 3/6 (50%) maintained CR at 6 months.
- Designations offer expedited development benefits: Priority Review, Rolling Review, Accelerated Approval eligibility.