Difference between revisions of "Blinatumomab (Blincyto)"
Jump to navigation
Jump to search
m |
|||
Line 16: | Line 16: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
− | *7/1/2014: Granted FDA | + | *7/1/2014: Granted FDA [http://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm Breakthrough Therapy designation] "for adults with [[Acute lymphocytic leukemia | Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)]]." |
*12/3/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm425597.htm Granted FDA accelerated approval] "for the treatment of [[Acute lymphocytic leukemia | Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL)]]." | *12/3/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm425597.htm Granted FDA accelerated approval] "for the treatment of [[Acute lymphocytic leukemia | Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL)]]." | ||
Revision as of 18:02, 4 September 2015
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
- Use of Blinatumomab (Blincyto) requires participation in the Blincyto Risk Evaluation and Mitigation Strategy (REMS) program.
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]
Diseases for which it is used
Patient drug information
- Patient information may be found in the Blinatumomab (Blincyto) package insert.[1]
History of changes in FDA indication
- 7/1/2014: Granted FDA Breakthrough Therapy designation "for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)."
- 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)."
Also known as
MT103, AMG 103