Blinatumomab is a BiTE-class (bi-specific T-cell engager) constructed monoclonal antibody formed by the recombinant fusion of an anti-CD3 single-chain variable fragment (scFV) and an anti-CD19 scFV through a short peptide linker. CD3 is an antigen expressed on the surface of T-cells, while CD19 is mostly expressed on the surface of malignant B-cells. Since blinatumomab has an affinity to both antigens, it redirects T-cells to tumor cells expressing CD19 and promotes tumor cell lysis and apoptosis.
Blinatumomab is manufactured by Amgen Inc. and marketed under the brand Blincyto. It was first approved by the FDA in December 2014 for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in relapsed and refractory patients. In March 2018, it was approved under the FDA’s accelerated approval program for the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children. Full approval for this indication was granted in June 2023.
Blinatumomab has a short half-life, requiring patients to receive a continuous infusion over 4-week cycles using a portable mini-pump for optimum delivery.
Blinatumomab is indicated for the treatment of adults and children with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). It is also indicated in adults and children for the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan", Buenos Aires, Argentina
Australian and New Zealand Children's Haematology/Oncology Group, Clayton, Victoria, Australia
North Adelaide- Womens and Childrens Hospital, Adelaide, Australia
Memorial Sloan Kettering Cancer Center, New York, New York, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Charité - Campus Benjamin Franklin, Berlin, Germany
University Hospital of Frankfurt (Main), Frankfurt (Main), Hessen, Germany
Universitätsklinikum Essen, Essen, Germany
Tohoku University Hospital, Sendai-shi, Miyagi, Japan
Nihon University Itabashi Hospital, Itabashi-ku, Tokyo, Japan
City of Hope National Medical Center, Duarte, California, United States
Oslo University Hospital, Oslo, Norway
IRCCS Ospedale Pediatrico Bambino Gesù Roma, Roma, Italy
Nicolaus Copernicus University Collegium Medicum, Bydgoszcz, Poland
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Almazov National Medical Research Centre, Saint Petersburg, Russian Federation
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation
National Medical Research Center of Oncology named after N.N. Blokhin, Moscow, Russian Federation
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
University Hospital Hradec Kralove,The 4th Department of Internal Medicine - Hematology, Hradec Králové, Czechia
University Hospital Olomouc, Hematooncology Clinic, Olomouc, Czechia
University Hospital Ostrava, Hematooncology Clinic, Ostrava, Czechia
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