BESPONSA (inotuzumab ozogamicin)
BESPONSA is indicated for the treatment of Acute Lymphoblastic Leukemia.
How BESPONSA Works
This drug consists of a CD22-directed antibody linked to a cytotoxic agent called N-acetyl-gamma-calicheamicin. After the antibody binds to CD22-expressing tumor cells, the complex is internalized and the cytotoxic agent is released into the cell via hydrolytic cleavage. The released agent induces double-strand DNA breaks, which results in cell cycle arrest and apoptotic cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-08-17
- Patent Cliff
- 2031
- Routes
- N/A
- Dosage Forms
- POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
BESPONSA Approval History
What BESPONSA Treats
1 indicationsBESPONSA is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
BESPONSA Boxed Warning
HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning. • Hepatotoxicity, includi...
WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. ( 5.1 ) • A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA ( 5.2 ) HEPATOTOXICITY, INCLUDING VOD • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. • Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. • Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. INCREASED RISK OF POST-HSCT NON-RELAPSE MORTALITY • There was higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate [see Warnings and Precautions (5.2) ] .
BESPONSA Target & Pathway
ProTarget
BESPONSA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 BESPONSA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BESPONSA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BESPONSA
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Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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 |
| NCT03150693 | A041501 NCI-2016-01981, U10CA180821 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT05748171 | B1931036 2023-509810-13-00 | Ph 2 | recruiting | A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL |
| 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 |
| NCT02981628 | AALL1621 NCI-2016-01494, AALL1621 | Ph 2 | recruiting | Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute 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 |
| 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 |
| NCT05456698 | IIT2022011 | Ph 2 | active not recruiting | Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy |
| NCT03856216 results posted | 2018-0860 NCI-2019-00531, 2018-0860 | Ph 2 | terminated | Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation |
| NCT05303792 | A042001 NCI-2022-01735, U10CA180821 | Ph 2 | active not recruiting | Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma |
| NCT01679119 INCA results posted | UCL 11/0475 | Ph 2 | completed | Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy |
| NCT04747912 | IRB20-1749 | Ph 2 | suspended | Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO) |
| NCT03441061 | 2015-0921 NCI-2018-00936, 2015-0921 | Ph 2 | active not recruiting | Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease |
| NCT03913559 | INOMRD NCI-2019-01062 | Ph 2 | terminated | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia |
| NCT05016947 | 21-196 | Ph 1 | active not recruiting | Venetoclax Plus Inotuzumab for B-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 |
| NCT05687032 results posted | B1931034 NCT05687032 | Ph 4 | completed | A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia |
| NCT05940961 | szINO | Ph 2 | recruiting | Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL |
| NCT02877303 | 2014-0845 NCI-2017-00596, 2014-0845 | Ph 2 | recruiting | Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT03104491 | CASE1916 | Ph 1, Ph 2 | recruiting | Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia |
| NCT06554626 | IIT20240070C | Ph 2 | recruiting | Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL |
| NCT06427330 | IIT2024022 | Ph 2 | recruiting | Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia |
| NCT01664910 results posted | 2012-0265 NCI-2012-02072, 2012-0265 | Ph 1, Ph 2 | completed | CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies |
| NCT03488225 results posted | 2015-0922 NCI-2018-00760, 2015-0922 | Ph 2 | terminated | Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT03962465 ALL-001 | 21417 | Ph 1 | active not recruiting | Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL |
| NCT02311998 results posted | 2014-0435 NCI-2014-02606, 2014-0435 | Ph 1, Ph 2 | completed | Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML |
| NCT03991884 | RG1004854 NCI-2019-03811, 8786 | Ph 1 | completed | Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia |
| NCT01925131 results posted | S1312 NCI-2013-01368, S1312 | Ph 1 | completed | S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia |
| NCT03851081 | I 66818 NCI-2019-00565, I 66818 | Ph 1, Ph 2 | withdrawn | Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia |
| NCT03094611 results posted | 2015-0870 NCI-2018-01237, 2015-0870 | Ph 2 | terminated | Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia |
| NCT01564784 results posted | B1931022 2011-005491-41 | Ph 3 | completed | A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia |
| NCT01232556 results posted | B1931008 3129K5-3303, 2010-020147-12 | Ph 3 | terminated | A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy |
| NCT01363297 results posted | B1931010 3129K6-1106 | Ph 2 | completed | Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia |
| NCT01535989 IOSI-LND-001 | IOSI-LND-001 | Ph 1 | completed | Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma |
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.
BESPONSA FDA Label Details
Indications & Usage
FDA Label (PDF)BESPONSA is indicated for the treatment of Acute Lymphoblastic Leukemia.
WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SI...
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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