Drugs / Blinatumomab
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Blinatumomab

also known as BLINCYTO · MEDI 538 · Blina · NSC# 765986 · AMG 103 · Blina-14 · bscCD19xCD3 · MT103

Monoclonal antibody targets CD19

Developed for
B-cell acute lymphoblastic leukemia · acute lymphoblastic leukemia · precursor B-cell acute lymphoblastic leukemia · B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) · adult acute lymphoblastic leukemia · B-cell adult acute lymphocytic leukemia · mixed phenotype acute leukemia · diffuse large B-cell lymphoma
+45 more · childhood acute lymphoblastic leukemia · chronic myeloid leukemia · lymphoblastic lymphoma · precursor lymphoblastic lymphoma/leukemia · acute leukemia of ambiguous lineage · B-cell childhood acute lymphoblastic leukemia · blast phase chronic myelogenous leukemia, BCR-ABL1 positive · Burkitt lymphoma · hematopoietic and lymphoid system neoplasm · leukemia · leukemia, myeloid, accelerated-phase · lymphoid leukemia · myasthenia gravis · non-Hodgkin lymphoma · Philadelphia-positive myelogenous leukemia · Richter transformation · systemic lupus erythematosus · acute leukemia · aggressive B-cell non-Hodgkin lymphoma · anti-HLA hyperimmunization · autoimmune encephalitis · B-cell chronic lymphocytic leukemia · B-cell lymphoma, unclassifiable, with features intermediate between diffuse large b-cell lymphoma and classical Hodgkin lymphoma · B-cell non-Hodgkin lymphoma · B-lymphoblastic leukemia/lymphoma MLL rearranged · blood group incompatibility · cancer · chronic lymphocytic leukemia/small lymphocytic lymphoma · disease related to solid organ transplantation · high grade B-cell lymphoma · high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · immune-mediated cerebellar ataxia · indolent B-cell non-Hodgkin lymphoma · lymphoblastic leukemia, acute, with lymphomatous features · mantle cell lymphoma · marginal zone lymphoma · mediastinal malignant lymphoma · myeloid leukemia · phosphohydroxylysinuria · plasma cell myeloma · relapsed/refractory diffuse large B-cell lymphoma · rheumatoid arthritis · Sjogren syndrome · steroid-resistant nephrotic syndrome · T-cell acute lymphoblastic leukemia
Investigated by
Amgen · National Cancer Institute (NCI) · M.D. Anderson Cancer Center · Institute of Hematology & Blood Diseases Hospital, China · Amgen Research (Munich) GmbH · The First Affiliated Hospital of Soochow University
+126 more · St. Jude Children's Research Hospital · Assistance Publique - Hôpitaux de Paris · First Affiliated Hospital of Zhejiang University · GIMEMA Foundation · Goethe University · Pfizer · The Children's Hospital of Zhejiang University School of Medicine · Ascentage Pharma Group Inc. · BeOne Medicines · Chen Suning · City of Hope Medical Center · Federal Research Institute of Pediatric Hematology, Oncology and Immunology · MedImmune LLC · Memorial Sloan Kettering Cancer Center · Merck Sharp & Dohme LLC · PETHEMA Foundation · Ruijin Hospital · Seoul National University Hospital · Servier · Sichuan University · West China Hospital · Zhejiang University · Aamu Pediatric Cancer Foundation · AbbVie · Abramson Cancer Center at Penn Medicine · Acreditar - Associação de Pais e Amigos das Crianças com Cancro · Acrotech Biopharma Inc. · Amgen Astellas Biopharma K.K. · Amgen Europe B.V · Anhui Provincial Children's Hospital · Beijing Tiantan Hospital · Beijing Tongren Hospital · Belgium Health Care Knowledge Centre · CZECRIN - Czech Clinical Research Infrastructure Network · Canadian Cancer Trials Group · Cancer Research UK · Cannonball Kid's Cancer · Cardiff University · Children's Hospital Medical Center, Cincinnati · Chonnam National University Hospital · Clinical Trial Center North (CTC North GmbH & Co. KG) · Da, Yuwei, M.D. · Dalian Women and Children's Medical Center · Dana-Farber Cancer Institute · Danish Cancer Society · Danish Child Cancer Foundation · Deutsche Krebshilfe e.V., Bonn (Germany) · Deutsche Leukämie- & Lymphom-Hilfe · Direction Générale de l'Offre de Soins · Dorothy Sipkins, MD, PhD · First Affiliated Hospital of Wannan Medical College · French Innovative Leukemia Organisation · Fujian Maternity and Child Health Hospital · Fujian Medical University Union Hospital · Fundação Rui Osório de Castro · German Federal Ministry of Education and Research · German Society for Pediatric Oncology and Hematology GPOH gGmbH · Grupo Português De Leucemias Pediátricas · Guizhou Provincial People's Hospital · HOVON Foundation · Ho Joon Im · Hospital Universitario Dr. Jose E. Gonzalez · Hunan Provincial People's Hospital · Imugene Limited · Incyte Corporation · Institute of Hematology and Blood Transfusion, Czech Republic · Israeli Medical Association · Jiangxi Province Children's Hospital · Karolinska Institutet · Kura Oncology, Inc. · Liping Dou · Lucile Packard Foundation for Children's Health · Ludwig-Maximilians - University of Munich · Mao Jianhua · all 132 on the full record

Regulatory milestones approvals, filings & regulatory actions · 14 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed acute lymphoblastic leukemia 1 milestone
Filed US (FDA) BLINCYTO acute lymphoblastic leukemia 2016-03-01

“today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ( FDA ) for BLINCYTO ® (blinatumomab)” amgen.com ↗

Filed B-cell acute lymphoblastic leukemia 1 milestone
Filed China (NMPA) BLINCYTO B-cell acute lymphoblastic leukemia 2021-05-06

“Regulatory activities for KYPROLIS and BLINCYTO are in progress, with new drug applications (NDAs) to the NMPA submitted in the fourth quarter 2019.” beonemedicines.com ↗

“Received acceptance of a sBLA and priority review in China of BLINCYTO® (blinatumomab)” beonemedicines.com ↗

Filed B-lymphoblastic leukemia with MYC rearrangement 1 milestone
Filed US (FDA) BLINCYTO B-lymphoblastic leukemia with MYC rearrangement 2018-02-14

“The sBLA for BLINCYTO was accepted by the FDA for priority review” amgen.com ↗

Filed refractory precursor T-lymphoblastic lymphoma/leukemia 2 milestones
Filed Japan (PMDA) — refractory precursor T-lymphoblastic lymphoma/leukemia 2018-01-09

“an application was submitted in Japan for the marketing authorization for bispecific CD19-directed CD3 T cell engager (BiTE® ) antibody construct blinatumomab” astellas.com ↗

Filed China (NMPA) BLINCYTO refractory precursor T-lymphoblastic lymphoma/leukemia —

“New Drug Applications for KYPROLIS and BLINCYTO have been filed in China.” amgen.com ↗

Approved Indication not stated 4 milestones
Label expansions (6) US (FDA) BLINCYTO — 2016-08-30 – 2024-06-14 fda.gov ↗
Filed US (FDA) BLINCYTO B-cell precursor ALL with minimal residual disease 2017-12-07

“The U.S. Food and Drug Administration ( FDA ) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO” amgen.com ↗

Approved EU (EMA) Blincyto — 2015-11-23 europa.eu ↗
Approved US (FDA) BLINCYTO — 2014-12-03 fda.gov ↗

Trials 151 · started per year

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US approved 2014
EU approved 2015
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT07706205 Sep 2026 → Dec 2027 expected blood group incompatibility West China Hospital Not yet recruiting No outcome recorded
Phase 0 NCT03173430 May 2017 → Jan 2019 plasma cell myeloma Abramson Cancer Center at Penn Medicine Terminated No outcome recorded Stop: Enrollment
Phase 121 trials
Phase 1 NCT07283640 Nov 2026 → Aug 2029 expected B-lymphoblastic leukemia/lymphoma MLL rearranged M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 1 NCT07133997 May 2026 → Jun 2028 expected B-cell acute lymphoblastic leukemia City of Hope Medical Center Recruiting No outcome recorded
Phase 1 NCT07052370 Sep 2025 → Dec 2028 expected hematopoietic and lymphoid system neoplasm St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 1 NCT06649006 Jan → Jul 2025 precursor B-cell acute lymphoblastic leukemia Amgen Completed No outcome recorded
Phase 1 NCT06789107 Dec 2024 → Dec 2027 expected systemic lupus erythematosus Mao Jianhua Recruiting No outcome recorded
Phase 1 NCT07677878 Dec 2024 → Nov 2028 expected B-cell acute lymphoblastic leukemia Liping Dou Recruiting No outcome recorded
Phase 1 NCT06607991 Sep 2024 → Sep 2026 overdue steroid-resistant nephrotic syndrome The Children's Hospital of Zhejiang University School of Medicine Recruiting No outcome recorded
Phase 1 NCT06507514 Apr 2024 → Apr 2028 expected B-cell acute lymphoblastic leukemia The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 1 NCT06125106 Nov 2023 → Jan 2025 acute lymphoblastic leukemia Zhejiang University Unknown No outcome recorded
Phase 1 NCT06063317 Oct 2023 → Feb 2026 cancer Imugene Limited Terminated No outcome recorded Stop: Business
Phase 1/214 trials
Phase 1/2 NCT07604233 Nov 2026 → Jun 2031 expected myeloid leukemia M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 1/2 NCT07313852 Jun 2026 → Jan 2029 expected B-cell acute lymphoblastic leukemia, B-cell adult acute lymphocytic leukemia Memorial Sloan Kettering Cancer Center Not yet recruiting No outcome recorded
Phase 1/2 NCT07134088 Dec 2025 → Mar 2031 expected B-cell acute lymphoblastic leukemia, precursor B-cell acute lymphoblastic leukemia Amgen Active not recruiting No outcome recorded
Phase 1/2 NCT06308588 Aug 2024 → May 2027 expected acute lymphoblastic leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT05848687 Nov 2023 → Dec 2028 expected acute lymphoblastic leukemia Tanja Andrea Gruber Recruiting No outcome recorded
Phase 1/2 NCT05192889 Aug 2022 → Jun 2024 overdue acute lymphoblastic leukemia St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 1/2 NCT04521231 Jan 2021 → Nov 2027 expected precursor B-cell acute lymphoblastic leukemia Amgen Active not recruiting No outcome recorded
Phase 1/2 NCT03512405 Aug 2019 → Nov 2025 overdue acute lymphoblastic leukemia City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1/2 NCT03114865 Sep 2017 → Oct 2026 expected precursor B-cell acute lymphoblastic leukemia Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Active not recruiting No outcome recorded
Phase 1/2 NCT03160079 Aug 2017 → Dec 2021 B-cell adult acute lymphocytic leukemia University of California, San Diego Completed No outcome recorded
Phase 277 trials · 2 met primary
Phase 2 NCT07178912 Jan 2027 → Sep 2031 expected acute leukemia, precursor lymphoblastic lymphoma/leukemia M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 2 NCT07636564 Oct 2026 → Apr 2031 expected B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, acute leukemia of ambiguous lineage SWOG Cancer Research Network Not yet recruiting No outcome recorded
Phase 2 NCT07840976 Oct 2026 → May 2028 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
Phase 2 NCT07852234 Sep 2026 → Oct 2027 expected Sjogren syndrome Beijing Tongren Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07301424 Jul 2026 → Dec 2027 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) University of Alberta Not yet recruiting No outcome recorded
Phase 2 NCT07643103 Jun 2026 → May 2028 expected precursor B-cell acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
Phase 2 NCT07573670 May 2026 → Dec 2027 expected mixed phenotype acute leukemia The First Affiliated Hospital of Soochow University Not yet recruiting No outcome recorded
Phase 2 NCT07192237 Apr 2026 → Oct 2030 acute lymphoblastic leukemia M.D. Anderson Cancer Center Suspended No outcome recorded
Phase 2 NCT07227584 Apr 2026 → Jul 2030 expected acute lymphoblastic leukemia Dana-Farber Cancer Institute Not yet recruiting No outcome recorded
Phase 2 NCT07153796 Jan 2026 → Sep 2031 expected B-cell acute lymphoblastic leukemia M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 2/38 trials
Phase 2/3 NCT06860269 May 2025 → Mar 2035 expected acute lymphoblastic leukemia Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 2/3 NCT06836973 Apr 2025 → Mar 2028 expected myasthenia gravis Da, Yuwei, M.D. Not yet recruiting No outcome recorded
Phase 2/3 NCT06882057 Mar 2025 → Dec 2029 expected B-cell acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 2/3 NCT06764238 Jan 2025 → Dec 2029 expected B-cell acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 2/3 NCT06684184 Nov 2024 → Dec 2025 overdue myasthenia gravis Zhongming Qiu Not yet recruiting No outcome recorded
Phase 2/3 NCT06607419 May 2024 → May 2025 overdue B-cell acute lymphoblastic leukemia Shanghai Jiao Tong University School of Medicine Recruiting No outcome recorded
Phase 2/3 NCT03117751 Mar 2017 → Sep 2026 overdue lymphoblastic leukemia, acute, with lymphomatous features St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 2/3 NCT02910063 Jan 2017 → Mar 2020 aggressive B-cell non-Hodgkin lymphoma Amgen Completed No outcome recorded
Phase 313 trials · 4 met primary · 1 missed
Phase 3 NCT05327894 Dec 2022 → Sep 2027 expected acute lymphoblastic leukemia, mixed phenotype acute leukemia Princess Maxima Center for Pediatric Oncology Recruiting No outcome recorded
Phase 3 NCT04994717 Nov 2021 → Sep 2029 expected precursor B-cell acute lymphoblastic leukemia Amgen Active not recruiting No outcome recorded
Phase 3 NCT05029531 Sep 2021 → Jul 2029 expected childhood acute lymphoblastic leukemia Federal Research Institute of Pediatric Hematology, Oncology and Immunology Recruiting No outcome recorded
Phase 3 NCT04722848 Sep 2021 → Sep 2027 expected adult acute lymphoblastic leukemia GIMEMA Foundation Active not recruiting No outcome recorded
Phase 3 NCT04530565 Jan 2021 → Jul 2028 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 3 NCT04307576 Jul 2020 → Jun 2033 expected acute lymphoblastic leukemia Mats Heyman Recruiting No outcome recorded
Phase 3 NCT03914625 Jul 2019 → Sep 2027 expected B-cell acute lymphoblastic leukemia, Down syndrome, lymphoblastic lymphoma National Cancer Institute (NCI) Active not recruiting Met primary
Phase 3 NCT03643276 Jul 2018 → Jul 2028 expected childhood acute lymphoblastic leukemia Martin Schrappe Recruiting No outcome recorded
Phase 3 NCT03476239 Oct 2017 → Aug 2019 acute lymphoblastic leukemia Amgen Completed No outcome recorded
Phase 3 NCT02393859 Nov 2015 → Jul 2019 acute lymphoblastic leukemia Amgen Completed Met primary
Phase 44 trials
Phase 4 NCT07689149 Jun 2026 → Dec 2029 expected anti-HLA hyperimmunization, disease related to solid organ transplantation West China Hospital Not yet recruiting No outcome recorded
Phase 4 NCT07686042 Jun 2026 → Dec 2028 expected autoimmune encephalitis, immune-mediated cerebellar ataxia Beijing Tiantan Hospital Not yet recruiting No outcome recorded
Phase 4 NCT06339775 Sep 2023 → Dec 2026 expected B-cell acute lymphoblastic leukemia Suping ZHANG Recruiting No outcome recorded
Phase 4 NCT04506086 Aug 2021 → Jul 2024 precursor B-cell acute lymphoblastic leukemia Amgen Terminated No outcome recorded Stop: Enrollment
Phase not applicable11 trials
— NCT06991920 Jun 2026 → Apr 2030 expected adult acute lymphoblastic leukemia, mixed phenotype acute leukemia Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
— NCT07454226 May 2026 → Mar 2028 expected acute lymphoblastic leukemia, phosphohydroxylysinuria Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
— NCT07493161 Apr 2026 → Mar 2028 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
— NCT07495631 Apr 2026 → Mar 2028 expected adult acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
— NCT07443592 Mar 2026 → Mar 2031 expected acute lymphoblastic leukemia PETHEMA Foundation Not yet recruiting No outcome recorded
— NCT07003737 Feb 2025 → Feb 2027 expected precursor B-cell acute lymphoblastic leukemia First Affiliated Hospital of Zhejiang University Recruiting No outcome recorded
— NCT06763302 Jan 2025 → Dec 2027 expected precursor B-cell acute lymphoblastic leukemia The Children's Hospital of Zhejiang University School of Medicine Not yet recruiting No outcome recorded
— NCT06658938 Nov 2024 → Oct 2026 expected — Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
— NCT06504186 Jul 2024 → Jun 2026 overdue — Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
— NCT06237192 Apr 2023 → Sep 2026 overdue precursor lymphoblastic lymphoma/leukemia National Research Center for Hematology, Russia Recruiting No outcome recorded
Phase not stated1 trial
— NCT02187354 — precursor B-cell acute lymphoblastic leukemia Amgen No longer available No outcome recorded
Comparator or background therapy16 trials
Phase 1 NCT04872790 Background Sep 2022 → Dec 2027 expected B-cell acute lymphoblastic leukemia, B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), mixed phenotype acute leukemia OHSU Knight Cancer Institute Active not recruiting No outcome recorded
Phase 1 NCT03751709 Background Feb 2020 → Mar 2023 B-cell acute lymphoblastic leukemia, adult acute lymphoblastic leukemia Cedars-Sinai Medical Center Completed No outcome recorded
Phase 1 NCT03595917 Background Jul 2018 → Nov 2026 expected B-cell acute lymphoblastic leukemia, B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), blast phase chronic myelogenous leukemia, BCR-ABL1 positive Marlise Luskin, MD Recruiting No outcome recorded
Phase 1/2 NCT07387926 Background Jul 2026 → Sep 2033 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), acute lymphoblastic leukemia Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 1/2 NCT07294677 Background Mar 2026 → Mar 2032 expected leukemia, lymphoma University of Chicago Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 41

DateIssuerRelease
2026-05-31 Ascentage Pharma Group Inc. Results Ascentage Pharma Presents Data on Olverembatinib in CML-LBP and Ph+ BCP-ALL at ASCO 2026 ascentage.com ↗
The combination regimen demonstrated encouraging clinical activity in patients with relapsed/refractory Ph+ BCP-ALL or CML-LBP, with strong response rates and minimal residual disease (MRD) clearance.
2025-06-15 Ascentage Pharma Group Inc. Results EHA 2025 | Multiple Studies Report Encouraging Data of Olverembatinib in Ph+ ALL ascentage.com ↗
Furthermore, studies on various combinations of olverembatinib (with venetoclax plus azacitidine, the VP regimen, blinatumomab, or inotuzumab ozogamicin) have shown encouraging results that revealed olverembatinib’s potential in offering more treatment options and improved long-term prognoses to patients with Ph+ ALL.
2024-12-07 Amgen Results BLINCYTO® (BLINATUMOMAB) ADDED TO CHEMOTHERAPY SIGNIFICANTLY IMPROVES SURVIVAL IN NEWLY DIAGNOSED PEDIATRIC PATIENTS WITH B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) amgen.com ↗
Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO ® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse.
2024-06-14 Amgen Regulatory FDA APPROVES BLINCYTO® (BLINATUMOMAB) IN CD19-POSITIVE PHILADELPHIA CHROMOSOME-NEGATIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) IN THE CONSOLIDATION PHASE amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved BLINCYTO ® (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.
2023-12-08 Amgen Results AMGEN HIGHLIGHTS HEMATOLOGY PORTFOLIO AT ASH 2023 amgen.com ↗
Multiple Investigator Sponsored Studies Support the Potential of BLINCYTO ® (blinatumomab) Across Acute Lymphoblastic Leukemia Treatment Paradigm
2023-06-21 Amgen Regulatory FDA GRANTS FULL APPROVAL FOR BLINCYTO® (BLINATUMOMAB) TO TREAT MINIMAL RESIDUAL DISEASE-POSITIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO ® (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, based on additional data from two Phase 3 studies that were submitted.
2022-12-13 Amgen Results BLINCYTO® (BLINATUMOMAB) ADDED TO CONSOLIDATION CHEMOTHERAPY SIGNIFICANTLY IMPROVES SURVIVAL IN ADULT PATIENTS WITH MEASURABLE RESIDUAL DISEASE-NEGATIVE B-LINEAGE ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) amgen.com ↗
Treatment with BLINCYTO in addition to consolidation chemotherapy reduced the risk of death by 58% compared to chemotherapy alone.
2022-05-04 BeOne Medicines Regulatory BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Pediatric Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL) beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the China National Medical Products Administration (NMPA) has granted conditional approval of BLINCYTO® (blinatumomab) for injection for the treatment of pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).
2021-12-06 Amgen Results Amgen Announces New Data Being Presented At ASH 2021 amgen.com ↗
Updated data from the Phase 3 '215 trial in children with high-risk first relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) showed BLINCYTO improved event-free survival (EFS) and overall survival (OS) versus chemotherapy before allogeneic hematopoietic stem cell transplant (alloHSCT).
2021-03-02 Amgen Results BLINCYTO® (Blinatumomab) Demonstrated Significantly Prolonged Event-Free Survival Compared With Consolidation Chemotherapy In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia amgen.com ↗
BLINCYTO demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) compared with chemotherapy.
2020-12-07 BeOne Medicines Regulatory BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Adult Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL) beonemedicines.com ↗
With this approval, BLINCYTO has become the first bispecific immunotherapy approved in China.
2019-09-24 Amgen Results Amgen Announces Positive Results From Two Phase 3 BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia amgen.com ↗
Enrollment was terminated early due to encouraging efficacy in the BLINCYTO arm and was based on a recommendation from the Independent Data Monitoring Committee (DMC).

All press releases naming this drug 42 releases

DateIssuerRelease

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 167 sources stand behind the page.

FieldValueCited text
Known as Blinatumomab “For high-risk patients, a combination of immunotherapy (blinatumomab - a bispecific CD3 / CD19 T-cell activator) and HSCT in the first remission was chosen.” NCT05029531 ↗
164

“Multiple studies have reported that blinatumomab achieves complete remission rates of 33-50% in refractory/relapsed Ph-negative B-ALL.” NCT07105579 ↗

“Blinatumomab is a CD19×CD3 bispecific T-cell engager (BiTE) administered via intravenous infusion.” NCT07689149 ↗

“Blinatumomab will be given intravenously up to five cycles.” NCT05931757 ↗

“Blinatumomab, Dasatinib, Methotrexate, and Dexamethasone” NCT06773936 ↗

NCT03751709 ↗

NCT07636564 ↗

NCT04746209 ↗

NCT03739814 ↗

NCT04334993 ↗

NCT03605589 ↗

Show 154 more sources

Known as AMG 103 “Blinatumomab (BLINCYTO , AMG 103, formerly also known as MT103 or bscCD19xCD3) is a novel single chain antibody construct in the class of the bispecific T-cell engager (BiTE®).” NCT04827745 ↗
Known as Blina “The induction therapy is a combination of Blinatumomab(Blina), Vindesine(VDS), Cyclophosphamide(CTX) and Dexamethasone(DXM).” NCT06742515 ↗
1

“including the anti-CD19 bispecific T-cell engager blinatumomab (BLINA, Blincyto®, Amgen).” NCT06860269 ↗

Known as Blina-14 “All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+” NCT06882057 ↗
Known as BLINCYTO “Blinatumomab (BLINCYTO) is a bi-specific T-cell engaging (BiTE®) antibody construct that transiently links CD3-positive T cells to CD19-positive B-cells, inducing T-cell...” NCT03931642 ↗
4

“Blinatumomab (BLINCYTO , AMG 103, formerly also known as MT103 or bscCD19xCD3) is a novel single chain antibody construct in the class of the bispecific T-cell engager (BiTE®).” NCT04827745 ↗

“including the anti-CD19 bispecific T-cell engager blinatumomab (BLINA, Blincyto®, Amgen).” NCT06860269 ↗

“Blinatumomab (Blincyto), an anti-CD19/anti-CD3 bi-specific T cell engager” NCT03173430 ↗

“Blinatumomab Injection [Blincyto]” NCT06250959 ↗

Known as bscCD19xCD3 “Blinatumomab (BLINCYTO , AMG 103, formerly also known as MT103 or bscCD19xCD3) is a novel single chain antibody construct in the class of the bispecific T-cell engager (BiTE®).” NCT04827745 ↗
Known as MEDI 538 “Dose one of MEDI 538 as a continuous IV infusion - dose level is 5 mg/m2/24h (Phase 1)” NCT00676871 ↗
2

NCT00676871 ↗

NCT00538096 ↗

Known as MT103 “Blinatumomab (BLINCYTO , AMG 103, formerly also known as MT103 or bscCD19xCD3) is a novel single chain antibody construct in the class of the bispecific T-cell engager (BiTE®).” NCT04827745 ↗
Known as NSC# 765986 “A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC# 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old...” NCT04546399 ↗
1

“A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy” NCT03914625 ↗

Action Deplete “resulting in T-cell activation and a cytotoxic T-cell response against CD19+ cells.” NCT00274742 ↗
Modality Other / unclassified “Bispecific T-Cell Engager MEDI-538” NCT00538096 ↗
Route Intravenous “by continuous intravenous infusion” NCT00274742 ↗
Target CD19 “against CD19 expressing cells” NCT01209286 ↗