Overview
Inotuzumab ozogamicin is an antibody-drug conjugate using linker and cytotoxic drug technology similar to that developed for the ground-breaking treatment Mylotarg (Gemtuzumab ozogamicin), which was approved by the US FDA in 2000 for the treatment of acute myeloid leukaemia. Inotuzumab ozogamicin consists of a recombinant humanised IgG4 kappa CD22-targeting monoclonal antibody covalently attached to calicheamicin derivative, N-acetyl-gamma-calicheamicin dimethylhydrazide, which is a potent DNA-binding cytotoxic agent . Developed by Pfizer and UCB, inotuzumab ozogamicin was granted approval by EU in June 2017 followed by FDA on August 17th, 2017 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ALL is a rapidly progressing cancer of the bone marrow that is associated with high mortality rates and low therapeutic response from standard chemotherapies in relasping conditions. In a randomized trial, inotuzumab ozogamicin displayed higher percentages of patients undergoing longer periods of complete remission with no evidence of disease in comparison to patients receiving alternative chemotherapy .
Background
Inotuzumab ozogamicin is an antibody-drug conjugate using linker and cytotoxic drug technology similar to that developed for the ground-breaking treatment Mylotarg (Gemtuzumab ozogamicin), which was approved by the US FDA in 2000 for the treatment of acute myeloid leukaemia. Inotuzumab ozogamicin consists of a recombinant humanised IgG4 kappa CD22-targeting monoclonal antibody covalently attached to calicheamicin derivative, N-acetyl-gamma-calicheamicin dimethylhydrazide, which is a potent DNA-binding cytotoxic agent . Developed by Pfizer and UCB, inotuzumab ozogamicin was granted approval by EU in June 2017 followed by FDA on August 17th, 2017 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ALL is a rapidly progressing cancer of the bone marrow that is associated with high mortality rates and low therapeutic response from standard chemotherapies in relasping conditions. In a randomized trial, inotuzumab ozogamicin displayed higher percentages of patients undergoing longer periods of complete remission with no evidence of disease in comparison to patients receiving alternative chemotherapy .
Indication
Indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).
Associated Conditions
- Refractory B-cell precursor acute lymphoblastic leukemia
- Relapsed B cell precursor Acute lymphoblastic leukemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/15 | Phase 2 | Recruiting | First Affiliated Hospital of Zhejiang University | ||
2024/05/23 | Phase 2 | Recruiting | |||
2024/04/26 | Phase 2 | Recruiting | |||
2024/03/01 | Phase 1 | Recruiting | |||
2023/10/17 | Phase 1 | Not yet recruiting | |||
2023/07/11 | Phase 2 | Recruiting | Sheng-Li Xue, MD | ||
2023/02/28 | Phase 2 | Recruiting | |||
2023/01/17 | Phase 4 | Active, not recruiting | |||
2022/12/09 | Phase 2 | Recruiting | |||
2022/10/27 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0100 | INTRAVENOUS | 0.25 mg in 1 mL | 3/6/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/28/2017 | ||
Authorised | 6/28/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BESPONSA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/VIAL | SIN15747P | POWDER, FOR SOLUTION | 1mg/vial | 7/17/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin for Injection | 国药准字SJ20210033 | 生物制品 | 注射剂 | 12/20/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BESPONSA inotuzumab ozogamicin 1 mg powder for injection vial | 288135 | Medicine | A | 5/17/2018 |