Tecartus granted European marketing authorization for treatment of relapsed or refractory acute lymphoblastic leukemia

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Sept 2022: The European Commission (EC) has authorised Kite’s CAR T-cell therapy Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and older with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukaemia. Kite is a Gilead Company (Nasdaq: GILD) (ALL).


Tecartus - brexucabtagene autoleucel


According to Christi Shaw, CEO of Kite, “With this approval, Tecartus becomes the first and only CAR T-cell therapy recommended for this patient population, addressing a large unmet medical need.” This is also the fourth approved use of Kite cell therapy in Europe, evidencing the advantages they provide to patients, particularly those with few other therapeutic alternatives.

The most prevalent type of ALL, which is an aggressive blood malignancy, is B-cell precursor ALL. Annually, ALL is diagnosed in about 64,000 persons worldwide. With the current standard-of-care medications, the median overall survival (OS) for individuals with ALL is just about eight months.

According to Max S. Topp, MD, professor and director of haematology at the University Hospital of Wuerzburg in Germany, “adults with relapsed or refractory ALL frequently undergo multiple treatments, including chemotherapy, targeted therapy, and stem cell transplant, creating a significant burden on a patient’s quality of life.” Patients in Europe today benefit from a significant improvement in care. Durable responses from Tecartus point to the possibility of a long-term remission and a novel treatment strategy.

The ZUMA-3 international multicenter, single-arm, open-label, registrational Phase 1/2 study of adult patients (18 years old) with relapsed or refractory ALL provided the results that supported the approval. With a median follow-up of 26.8 months, this study showed that 71% of the evaluable patients (n=55) experienced complete remission (CR) or CR with partial haematological recovery (CRi). In a larger data set, the median overall survival for all patients who received key doses (n=78) was more than two years (25.4 months), and for responders, it was nearly four years (47 months) (patients who achieved CR or CRi). The median duration of remission (DOR) among patients whose efficacy could be evaluated was 18.6 months.

The safety outcomes among the patients given Tecartus at the target dose (n=100) were consistent with the drug’s known safety profile. 25% and 32% of patients, respectively, experienced grade 3 or higher cytokine release syndrome (CRS) and neurologic adverse events, which were typically adequately controlled.

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