home > news > detailed info


Kite Pharma

Stockley Park, UK – 7 September 2022
– Kite, a Gilead Company, today announced that the European Commission (EC) has approved its CAR T-cell therapy Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukaemia (ALL).

“This approval makes brexucabtagene autoleucel the first and only CAR T-cell therapy indicated for this population of patients, addressing a significant unmet medical need,” said Christi Shaw, CEO, Kite. “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.”

ALL is an aggressive type of blood cancer; the most common form is B cell precursor ALL.[1] Globally, approximately 64,000 people are diagnosed with ALL each year.[2],[3] Half of adults living with ALL will relapse, and median overall survival (OS) with current standard-of-care treatments is approximately just eight months.[4],[5]

“Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant, creating a significant burden on a patient’s quality of life,” said Max S. Topp, MD, professor and head of Hematology, University Hospital of Wuerzburg, Germany. “Patients in Europe now have a meaningful advancement in treatment. Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.”

The approval is supported by data from the ZUMA-3 international multicentre, single-arm, open-label, registrational Phase 1/2 study of adult patients (≥18 years old) with relapsed or refractory ALL. This study demonstrated that 71% of the evaluable patients (n=55) achieved complete remission (CR) or CR with incomplete haematological recovery (CRi) with a median follow-up of 26.8 months.[6] In an extended data set of all pivotal dosed patients (n=78) the median overall survival for all patients was more than two years (25.4 months) and almost four years (47 months) for responders (patients who achieved CR or CRi).6,[7] Among efficacy-evaluable patients, median duration of remission (DOR) was 18.6 months.6

Among the patients treated with brexucabtagene autoleucel at the target dose (n=100) safety results were consistent with the known safety profile for brexucabtagene autoleucel. Grade 3 or higher cytokine release syndrome (CRS) and neurologic adverse reactions occurred in 25% and 32% of patients, respectively, and were generally well managed. [8],[9],[10]

[1] Leukaemia Care. B-cell Acute Lymphoblastic Leukaemia (ALL). Available at: Accessed September 2022.
[2] Dong, Y, et al. Leukemia incidence trends at the global, regional, and national level between 1990 and 2017. Exp Hematol Oncol 9, 14 (2020). Accessed September 2022.
[3] Leukemia and lymphoma Society Canada. Facts and Statistics. About Blood Cancers. Available at: Accessed September 2022.
[4] Kantarjian H, et al. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med (2017) 376: 836-847.
[5] Kantarjian H, et al. Inotuzumab Ozogamicin Versus Standard of Care in Relapsed or Refractory Acute Lymphoblastic Leukemia: Final Report and Long-Term Survival Follow-Up From the Randomized, Phase 3 INO-VATE Study. Cancer (2019) 125(14):2474-2487.
[6] Bijal D, et al. Two-year follow-up of KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adult patients (Pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) in ZUMA-3. Journal of Clinical Oncology (2022) 40:16_suppl, 7010-7010.
[7] Data on file. Figure Kaplan-Meier Plot of Overall Survival with CR+CRi vs. Others using Independent Review (Phase 1, 1e6 Dose Level and Phase 2, Safety Analysis Set)
[8] Data on file. Table Ad-hoc: Subject Incidence of Treatment-emergent Cytokine Release Syndrome Adverse Events by Preferred Term and Worst Grade (ZUMA-2 and ZUMA-3) (Safety Analysis Set)
[9] Data on file. Table Ad-hoc: Subject Incidence of Treatment-emergent Neurologic Events by Preferred Term and Worst Grade - Method 1 (ZUMA-2 and ZUMA-3) (Safety Analysis Set)
[10] European Medicines Agency. Tecartus® (autologous anti-CD19-transduced CD3+ cells) SPC. Available at: Accessed September 2022.
[11] NHS. Acute lymphoblastic leukaemia (ALL). Available at: Accessed September 2022.
[12] Leukaemia Care. B-cell Acute Lymphoblastic Leukaemia (ALL). Available at: Accessed September 2022.
phone (310) 824-9999
email 2400 Broadway Santa Monica, CA 90404
Print this page
Send to a friend
News and Press Releases

Foundational partnership with Paradigm4 enables Alnylam Pharmaceuticals to rapidly accelerate RNAi- based drug target discovery

25th October 2022: Paradigm4’s REVEAL Integrative Analytics platform enables Alnylam Pharmaceuticals to discover novel, genetically-validated drug targets from population scale biobank genotype-phenotype datasets and underlies the extraordinary pace and productivity of Alnylam’s RNAi therapeutics pipeline.
More info >>

White Papers

Pharmaceuticals and Healthcare Products

Turkish Cargo

Pharmaceuticals are requiring safe and reliable transportation for being highly temperature sensitive products. Thosepharmaceuticals are; diagnostics, vaccines drugs, sera, plasma, protein clinical trials, biotechnological material, pills and all kind of medicines. Turkish Cargo transports all kind of pharmaceuticals, and has been carrying out its operations of transporting and storing drugs and temperature-sensitive medical supplies successfully and with the experience of 80 years; since 1936.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement