Spain Approves the First Potentially Low-Cost Academically Manufactured CD19 CAR-T for Adult ALL Patients; Could EMA Approval be Next?

On Wednesday, February 10, the Spanish Agency of Medicines and Medical Devices (AEMPS) announced (press release) the approval of ARI-0001 (autologous CD19 CAR-T) for the treatment of ≥3L adult r/r ALL. ARI-0001 has become the first academically manufactured CD19 CAR-T approved by a regulatory agency. The approval was based on data from the Ph1 CART19-BE-01 trial. Below, Celltelligence provides insights on how ARI-0001’s point-of-care manufacturing model and competitive price could impact commercially available CAR-Ts.

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