Difference between revisions of "Blinatumomab (Blincyto)"
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*7/11/2017: Granted FDA regular approval for the treatment of relapsed or refractory [[B-cell_acute_lymphoblastic_leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]] in adults and children. ''(Based on TOWER, MT103-205, and ALCANTARA)'' | *7/11/2017: Granted FDA regular approval for the treatment of relapsed or refractory [[B-cell_acute_lymphoblastic_leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]] in adults and children. ''(Based on TOWER, MT103-205, and ALCANTARA)'' | ||
*3/29/2018: Granted FDA accelerated approval for the treatment of adult and pediatric patients with [[B-cell_acute_lymphoblastic_leukemia|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)'' | *3/29/2018: Granted FDA accelerated approval for the treatment of adult and pediatric patients with [[B-cell_acute_lymphoblastic_leukemia|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)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *11/23/2015: Initial authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' AMG 103, MEDI538, MT103 | *'''Code names:''' AMG 103, MEDI538, MT103 | ||
Revision as of 00:13, 1 January 2023
General information
Class/mechanism: Bi-specific T-cell engager (BiTE) antibody that targets CD19 (expressed on B cells) and CD3 (expressed on T cells).[1][2][3]
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.[1]
Toxicity management
- Use of Blinatumomab (Blincyto) requires participation in the Blincyto Risk Evaluation and Mitigation Strategy (REMS) program.
- Immunotherapy toxicity management
Diseases for which it is used
Patient drug information
- Patient information may be found in the Blinatumomab (Blincyto) package insert.[1]
- Blinatumomab (Blincyto) patient drug information (Chemocare)[4]
- Blinatumomab (Blincyto) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 12/3/2014: 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)
- 7/11/2017: 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)
- 3/29/2018: 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)
History of changes in EMA indication
- 11/23/2015: Initial authorization
Also known as
- Code names: AMG 103, MEDI538, MT103
- Brand name: Blincyto