The European Commission has approvedGilead Science IncGILD company Kite Pharma’s CAR T-cell therapy Tecartus (brexucabtagene autoleucel) for patients 26 years and above with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
“This approval makes Tecartus the first and only CAR T-cell therapy indicated for this population of patients,” said Christi Shaw, CEO of Kite.
The approval is supported by data from the ZUMA-3 Phase 1/2 study demonstrating that 71% of the evaluable patients achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) with a median follow-up of 26.8 months.
In an extended data set of all pivotal dosed patients, the median overall survival for all patients was more than two years (25.4 months) and almost four years (47 months) for patients who achieved CR or CRi.
Among efficacy-evaluable patients, the median duration of remission was 18.6 months.
Safety results were consistent with the known safety profile. Grade 3 or higher cytokine release syndrome and neurologic adverse reactions occurred in 25% and 32% of patients and were generally well managed.
Price Action: GILD shares closed lower by 0.67% at $63.39 on Tuesday.
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