Difference between revisions of "Blinatumomab (Blincyto)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *12 | + | *2014-12-03: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm425597.htm Granted FDA accelerated approval] for the treatment of [[Biomarkers#BCR-ABL1|Philadelphia chromosome]]-[[Biomarkers#Normal_expression|negative]] relapsed or refractory [[B-cell_acute_lymphoblastic_leukemia | 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_acute_lymphoblastic_leukemia|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_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== | ==History of changes in EMA indication== | ||
| − | *11 | + | *2015-11-23: Initial authorization |
| + | ==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_acute_lymphoblastic_leukemia,_pediatric|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-cell_acute_lymphoblastic_leukemia|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%. | ||
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==Also known as== | ==Also known as== | ||
*'''Code names:''' AMG 103, MEDI538, MT103 | *'''Code names:''' AMG 103, MEDI538, MT103 | ||
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[[Category:FDA approved in 2014]] | [[Category:FDA approved in 2014]] | ||
[[Category:EMA approved in 2015]] | [[Category:EMA approved in 2015]] | ||
| + | [[Category:Health Canada approved in 2015]] | ||
Revision as of 17:32, 29 March 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
- 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)
History of changes in EMA indication
- 2015-11-23: Initial authorization
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%.
Also known as
- Code names: AMG 103, MEDI538, MT103
- Brand name: Blincyto