Blinatumomab (Blincyto)

General information

Class/mechanism: Bi-specific T-cell engager antibody that targets CD19 (expressed on B cells) and CD3 (expressed on T cells).
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Toxicity management

• Use of Blinatumomab (Blincyto) required participation in the Blincyto Risk Evaluation and Mitigation Strategy (REMS) program until February 2023.
• Immunotherapy toxicity management

Diseases for which it is used

• Acute lymphoblastic leukemia, infant
• B-cell acute lymphoblastic leukemia
  • B-cell acute lymphoblastic leukemia, Ph-positive
  • B-cell acute lymphoblastic leukemia, pediatric
• Diffuse large B-cell lymphoma

Patient drug information

• Patient information may be found in the Blinatumomab (Blincyto) package insert.
• Blinatumomab (Blincyto) patient drug information (Chemocare)
• Blinatumomab (Blincyto) patient drug information (UpToDate)

History of changes in FDA indication

• 2014-12-03: Granted FDA accelerated approval for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL). (Based on MT103-211)
• 2017-07-11: Granted FDA regular approval for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children. (Based on TOWER, MT103-205, and ALCANTARA)
• 2018-03-29: Granted FDA accelerated approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. (Based on BLAST)
  • 2023-06-21: Converted to regular approval for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with measurable residual disease (MRD) greater than or equal to 0.1%. (Based on COG AALL1331 & Amgen 20120215)

History of changes in EMA indication

• 2015-11-23: Initial authorization as Blincyto. Blincyto is indicated for the treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). (Based on MT103-211 & MT103-206)
• 2019-01-18: Extension of indication to include the treatment of adults with Philadelphia chromosome-negative CD19 positive B precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% for BLINCYTO monotherapy.
• 2020-12-22: To modify the approved therapeutic indication to include the treatment of Philadelphia chromosome positive CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL) in adult patients with relapsed or refractory ALL who have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment.
• 2021-06-24: Extension of indication to include the use of blinatumomab as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy.

History of changes in Health Canada indication

• 2015-12-22: Initial notice of compliance with conditions
• 2017-04-28: Notice of compliance with conditions for the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.
• 2017-11-16: Conditions were met
• 2019-12-19: Notice of compliance with conditions for the treatment of patients with Philadelphia chromosome-negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

History of changes in PMDA indication

• 2018-09-21: Newly indicated for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.

Also known as

• Code names: AMG-103, MEDI-538, MT-103
• Brand name: Blincyto