Novartis’ Kymriah Approved by European Commission

The European Commission approved Novartis’ CAR-T cell therapy Kymriah for treating pediatric r/r B-cell acute lymphocytic leukemia (ALL).

The approval gives Novartis the distinction of being the only company with an approved CAR-T cell therapy for pediatric r/r B-cell ALL and the first to receive EU and U.S. approval in two distinct indications.

The Commission’s decision was based on the first global CAR-T registration trials, which used patients from eight European countries. The trial showed a consistent safety profile and durable responses in r/r pediatric B-cell ALL and r/r Diffuse Large B Cell Lymphoma.