Difference between revisions of "Blinatumomab (Blincyto)"

Revision as of 00:38, 15 June 2024

General information

Class/mechanism: Bi-specific T-cell engager 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) required participation in the Blincyto Risk Evaluation and Mitigation Strategy (REMS) program until February 2023.
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)
- 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)
2024-06-14: Approved for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy. (Based on ECOG-ACRIN E1910)

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

References

[insert-1] 1.0 ^1.1 ^1.2 Blinatumomab (Blincyto) package insert

[2] Blinatumomab (Blincyto) package insert (locally hosted backup)

[3] Blincyto manufacturer's website

[4] Blinatumomab (Blincyto) patient drug information (Chemocare)

[5] Blinatumomab (Blincyto) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

@@ Line 1: / Line 1: @@
 ==General information==
-Class/mechanism: Bi-specific T-cell engager (BiTE) antibody that targets CD19 (expressed on B cells) and CD3 (expressed on T cells).<ref name=insert>[http://blincyto.com/blincyto_pi_hcp_english.pdf Blinatumomab (Blincyto) package insert]</ref><ref>[[Media:Blinatumomab.pdf | Blinatumomab (Blincyto) package insert (locally hosted backup)]]</ref><ref>[http://blincyto.com Blincyto manufacturer's website]</ref>
+Class/mechanism: Bi-specific T-cell engager antibody that targets CD19 (expressed on B cells) and CD3 (expressed on T cells).<ref name=insert>[https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/blincyto/blincyto_pi_hcp_english.pdf Blinatumomab (Blincyto) package insert]</ref><ref>[[:File:Blinatumomab.pdf | Blinatumomab (Blincyto) package insert (locally hosted backup)]]</ref><ref>[http://blincyto.com Blincyto manufacturer's website]</ref>
 <br>Route: IV
 <br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
+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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
+==Toxicity management==
+*Use of Blinatumomab (Blincyto) required participation in the [http://www.blincytorems.com/ Blincyto Risk Evaluation and Mitigation Strategy (REMS) program] until February 2023.
+*[[Immunotherapy toxicity management]]
 ==Diseases for which it is used==
-*[[Acute lymphocytic leukemia]]
+*[[Acute lymphoblastic leukemia, infant]]
-# Topp MS, Kufer P, Gökbuget N, Goebeler M, Klinger M, Neumann S, Horst HA, Raff T, Viardot A, Schmid M, Stelljes M, Schaich M, Degenhard E, Köhne-Volland R, Brüggemann M, Ottmann O, Pfeifer H, Burmeister T, Nagorsen D, Schmidt M, Lutterbuese R, Reinhardt C, Baeuerle PA, Kneba M, Einsele H, Riethmüller G, Hoelzer D, Zugmaier G, Bargou RC. Targeted therapy with the T-cell-engaging antibody blinatumomab of chemotherapy-refractory minimal residual disease in B-lineage acute lymphoblastic leukemia patients results in high response rate and prolonged leukemia-free survival. J Clin Oncol. 2011 Jun 20;29(18):2493-8. Epub 2011 May 16. [http://www.ncbi.nlm.nih.gov/pubmed/21576633 PubMed]
+*[[B-cell acute lymphoblastic leukemia]]
-# '''Update:''' Topp MS, Gökbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Köhne-Volland R, Brüggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmüller G, Kneba M, Hoelzer D, Kufer P, Bargou RC. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012 Dec 20;120(26):5185-7. Epub 2012 Sep 28. [http://www.ncbi.nlm.nih.gov/pubmed/23024237 PubMed]
+**[[B-cell acute lymphoblastic leukemia, Ph-positive]]
-# Topp MS, Gökbuget N, Zugmaier G, Klappers P, Stelljes M, Neumann S, Viardot A, Marks R, Diedrich H, Faul C, Reichle A, Horst HA, Brüggemann M, Wessiepe D, Holland C, Alekar S, Mergen N, Einsele H, Hoelzer D, Bargou RC. Phase II Trial of the Anti-CD19 Bispecific T Cell-Engager Blinatumomab Shows Hematologic and Molecular Remissions in Patients With Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia. J Clin Oncol. 2014 Nov 10.  [Epub ahead of print] [http://www.ncbi.nlm.nih.gov/pubmed/25385737 PubMed]
+**[[B-cell acute lymphoblastic leukemia, pediatric]]
+*[[Diffuse large B-cell lymphoma]]
 ==Patient drug information==
-*Patient information may be found in the [http://blincyto.com/blincyto_pi_hcp_english.pdf Blinatumomab (Blincyto) package insert].<ref name=insert></ref>
+*Patient information may be found in the [https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/blincyto/blincyto_pi_hcp_english.pdf Blinatumomab (Blincyto) package insert].<ref name=insert></ref>
+*[https://chemocare.com/druginfo/blinatumomab.aspx Blinatumomab (Blincyto) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/blinatumomab.aspx Blinatumomab (Blincyto) patient drug information (Chemocare)]</ref>
+*[http://www.uptodate.com/contents/blinatumomab-patient-drug-information Blinatumomab (Blincyto) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/blinatumomab-patient-drug-information Blinatumomab (Blincyto) patient drug information (UpToDate)]</ref>
 ==History of changes in FDA indication==
-*7/1/2014: Granted FDA breakthrough therapy designation "for adults with [[Acute lymphocytic leukemia | Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)]]."
+*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)''
-*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)]]."
+*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)''
+**2023-06-21: Converted to regular approval for the treatment of adult and pediatric patients with CD19-positive [[B-cell_acute_lymphoblastic_leukemia|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)''
+*2024-06-14: Approved for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative [[B-cell_acute_lymphoblastic_leukemia|B-cell precursor acute lymphoblastic leukemia]] (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy. ''(Based on ECOG-ACRIN E1910)''
+==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-cell_acute_lymphoblastic_leukemia|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-cell_acute_lymphoblastic_leukemia|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_acute_lymphoblastic_leukemia|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-cell_acute_lymphoblastic_leukemia|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_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%.
+==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==
-MT103, AMG 103
+*'''Code names:''' AMG-103, MEDI-538, MT-103
+*'''Brand name:''' Blincyto
 ==References==
 <references/>
-[[Category:Drug index]]
+[[Category:Drugs]]
-[[Category:Chemotherapy]]
+[[Category:Intravenous medications]]
-[[Category:Intravenous chemotherapy]]
+[[Category:Mutation-specific medications]]
-[[Category:Immunotherapy]]
+[[Category:Anti-CD19-CD3 bispecific antibodies]]
-[[Category:Antibody medications]]
-[[Category:BiTE antibodies]]
-[[Category:Anti-CD19 antibodies]]
-[[Category:Anti-CD3 antibodies]]
-[[Category:Acute lymphocytic leukemia medications]]
+[[Category:Acute lymphoblastic leukemia, infant medications]]
+[[Category:B-cell acute lymphoblastic leukemia medications]]
+[[Category:Diffuse large B-cell lymphoma medications]]
-[[Category:Drugs FDA approved in 2014]]
+[[Category:FDA approved in 2014]]
+[[Category:EMA approved in 2015]]
+[[Category:Health Canada approved in 2015]]
+[[Category:PMDA approved in 2018]]