Tecartus (brexucabtagene autoleucel), Kite Pharma’s CAR T-cell therapy for mantle cell lymphoma, is on track to becoming approved in the EU for an expanded indication – acute lymphoblastic leukemia (ALL).
The European Medicines Agency’s human medicines committee, the CHMP, recommended in favor of authorizing the new indication last week. If approved, Tecartus will become the first CAR (chimeric antigen receptor) T-cell therapy in Europe for treating adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute ALL, said Kite, a Gilead company
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