Kite Wins EMA Recommendation To Market Tecartus For Leukemia Patients

The European Medicines Agency has recommended new uses for six approved products, including the CAR T-cell therapy Tecartus. 

CAR T Therapy written in white chalk on a black chalkboard isolated on white
Tecartus is administered as a one-time infusion • Source: Shutterstock

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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