BLINCYTO (blinatumomab)
BLINCYTO is indicated for the treatment of Acute Lymphoblastic Leukemia.
How BLINCYTO Works
Blinatumomab functions by simultaneously binding to CD19 expressed on B-lineage cells and CD3 expressed on T-cells. This connection activates endogenous T-cells by linking the T-cell receptor complex directly to benign or malignant B-cells, forming a cytolytic synapse. The resulting activation leads to the production of cytolytic proteins, the release of inflammatory cytokines, and T-cell proliferation. These biological actions culminate in the redirected lysis and destruction of CD19-positive cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-12-03
- Patent Cliff
- 2031
- Revenue
- $413M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BLINCYTO Approval History
What BLINCYTO Treats
1 indicationsBLINCYTO is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
BLINCYTO Boxed Warning
CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticosteroids as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ] . Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) which may be se...
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticosteroids as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ] . Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticosteroids as recommended. ( 2.4 , 5.1 ) Neurological toxicities, including immune effector cell - associated neurotoxicity syndrome (ICANS), which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended. ( 2.4 , 5.2 )
BLINCYTO Target & Pathway
ProTarget
A protein expressed on B-cells throughout their development. CD19 is a key target for CAR-T cell therapies in B-cell leukemias and lymphomas, where engineered T-cells are directed to kill CD19-expressing cancer cells.
BLINCYTO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BLINCYTO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BLINCYTO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BLINCYTO
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
109 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04530565 | NCI-2020-06381 NCI-2020-06381, EA9181 | Ph 3 | active not recruiting | Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults |
| NCT06124157 | NCI-2023-09214 NCI-2023-09214, AALL2131 | Ph 2 | recruiting | A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT06649006 results posted | 20230258 | Ph 1 | completed | Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL) |
| NCT07387926 | CABL001L12101 2025-522019-40 | Ph 1, Ph 2 | not yet recruiting | Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL) |
| NCT03739814 | NCI-2018-02484 NCI-2018-02484, A041703 | Ph 2 | recruiting | Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia |
| NCT06317662 | NCI-2024-01994 NCI-2024-01994, AALL2321 | Ph 2 | recruiting | Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia |
| NCT07570173 | 1045-005 MK-1045-005, 2025-522267-15-00 | Ph 2, Ph 3 | recruiting | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
| NCT06308588 | 2024-0054 NCI-2024-02121 | Ph 1, Ph 2 | recruiting | Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia |
| NCT04994717 | 20190360 2023-503640-14 | Ph 3 | active not recruiting | Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia |
| NCT06570798 | 20240033 2024-514382-19 | Ph 2 | recruiting | A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases |
| NCT07573670 | MPAL-1 | Ph 2 | not yet recruiting | A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia |
| NCT04872790 | STUDY00022691 NCI-2021-01791, STUDY00022691 | Ph 1 | active not recruiting | Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia |
| NCT07178912 | 2025-0934 NCI-2025-06675 | Ph 2 | not yet recruiting | Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL) |
| NCT07283640 | 2025-0932 NCI-2025-09116 | Ph 1 | not yet recruiting | A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia |
| NCT07192237 | 2025-0933 NCI-2025-07132 | Ph 2 | not yet recruiting | Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia |
| NCT07153796 | 2025-0935 NCI-2025-06510 | Ph 2 | active not recruiting | A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia |
| NCT04307576 | ALLTogether1 | Ph 3 | recruiting | A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia |
| NCT03959085 | AALL1732 NCI-2019-02845, AALL1732 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT02101853 results posted | NCI-2014-00631 NCI-2014-00631, s15-00970 | Ph 3 | active not recruiting | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT03914625 | NCI-2019-02187 NCI-2019-02187, AALL1731 | Ph 3 | active not recruiting | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia |
| NCT07564453 FLOW | ALL-03 | Ph 2 | recruiting | Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia |
| NCT02003222 results posted | NCI-2013-02229 NCI-2013-02229, ECOG-E1910 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia |
| NCT06533748 | SJALL23H NCI-2024-06013 | Ph 2 | recruiting | Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma |
| NCT04521231 | 20180257 2023-506136-32 | Ph 1, Ph 2 | recruiting | A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL |
| NCT02879695 results posted | NCI-2016-01300 NCI-2016-01300, ETCTN10030 | Ph 1 | active not recruiting | Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia |
| NCT06287229 | 2023-0627 NCI-2024-01756 | Ph 1, Ph 2 | recruiting | Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab |
| NCT07134088 | 20220107 | Ph 1, Ph 2 | active not recruiting | A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia |
| NCT05645718 | 2022-0312 NCI-2022-10168 | Ph 2 | recruiting | Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia |
| NCT05848687 | IRB-68271 PEDSHEMALL0015, NCI-2023-04129 | Ph 1, Ph 2 | recruiting | TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II |
| NCT05519579 | NSH 1354 | Ph 2 | recruiting | Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia |
| NCT02143414 results posted | NCI-2014-01047 NCI-2014-01047, SWOG-S1318 | Ph 2 | active not recruiting | Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia |
| NCT03849651 results posted | HAP2HCT NCI-2019-00338 | Ph 2 | active not recruiting | TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies |
| NCT05327894 Interfant-21 | 2021-000213-16 | Ph 3 | recruiting | Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia |
| NCT02997761 | 945122 UCDCC#266, UCDCC#266 | Ph 2 | completed | Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia |
| NCT04329325 | 19-343 | Ph 2 | active not recruiting | Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia |
| NCT07133997 | 24738 NCI-2025-05656, 24738 | Ph 1 | recruiting | Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia |
| NCT07476729 | IntReALL BCP 2020 2023-509392-17-00 | Ph 3 | not yet recruiting | International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) |
| NCT06063317 OASIS | CF33-CD19-101 | Ph 1 | terminated | A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) |
| NCT07294677 CAVALRY | IRB25-1773 | Ph 1, Ph 2 | recruiting | CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL |
| NCT07223190 AUDAX | 20240113 2025-523291-23 | Ph 3 | not yet recruiting | A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia |
| NCT03263572 | 2016-0792 NCI-2018-01078, 2016-0792 | Ph 2 | recruiting | Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia |
| NCT03147612 | 2016-0402 NCI-2018-01186, 2016-0402 | Ph 2 | active not recruiting | Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia |
| NCT06054113 | 20190359 | Ph 2 | active not recruiting | Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) |
| NCT07052370 | HAP3HCT NCI-2025-04293 | Ph 1 | recruiting | TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies |
| NCT07297914 FORUM2 | FORUM2 2025-522052-13-00 | Ph 2, Ph 3 | not yet recruiting | Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL |
| NCT01371630 | 2010-0991 NCI-2011-01123, 2010-0991 | Ph 1, Ph 2 | recruiting | Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT06387121 | IIT2023060 | Ph 2 | recruiting | Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL |
| NCT03117751 | TOT17 NCI-2017-00582 | Ph 2, Ph 3 | active not recruiting | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma |
| NCT02568553 | NCI-2015-01640 NCI-2015-01640, PHI-79 | Ph 1 | completed | Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma |
| NCT07227584 | 25-533 | Ph 2 | not yet recruiting | ALL Backbone in AYAs |
Showing 50 of 109 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BLINCYTO FDA Label Details
Indications & Usage
FDA Label (PDF)BLINCYTO is indicated for the treatment of Acute Lymphoblastic Leukemia.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticost...
Pro Intelligence Preview
Deep insights for BLINCYTO
Revenue Insights
- • Q4-2025: $413M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • 108 total trials
- • Stage: Growth
Competitive Landscape
- • 19 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment