The European Commission (EC) has granted marketing authorisation for Gilead Sciences subsidiary Kite’s CAR T-cell therapy Tecartus (brexucabtagene autoleucel) to treat relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukaemia (ALL).
The treatment is indicated for usage in adults aged 26 years and older.
The approval is based on findings from the global, single-arm, multicentre, registrational, open-label Phase I/II ZUMA-3 clinical trial of Tecartus to treat r/r ALL.
It enrolled adult ALL patients aged 18 years or above whose disease is refractory to or relapsed after standard systemic therapy or hematopoietic stem cell transplantation.
According to the trial findings, 71% of the evaluable subjects attained a complete remission (CR) or CR with incomplete haematological recovery (CRi) with 26.8 months of median follow-up.
The median overall survival was found to be 25.4 months and 47 months for all patients and responders, respectively.
In efficacy-evaluable subjects, the median duration of remission (DOR) was 18.6 months.
Among subjects who received the target dose of Tecartus, safety data was in line with its known safety profile.
Additionally, 25% and 32% of the subjects had Grade 3 or higher cytokine release syndrome and neurologic adverse reactions, respectively, and were found to be well managed.
The latest approval became the fourth indication for Kite’s two cell therapies in Europe.
Kite CEO Christi Shaw said: “This approval makes Tecartus the first and only CAR T-cell therapy indicated for this population of patients, addressing a significant unmet medical need.
“This is also the fourth indication in Europe for which a Kite cell therapy is approved, clearly demonstrating the benefits they offer to patients, especially those with limited treatment options.”
An aggressive blood cancer form, ALL arises when abnormal white blood cells build up in the bone marrow until no room is left for the formation of blood cells.
In June, the EC granted marketing authorisation for Kite’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), for r/r follicular lymphoma.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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