Overview
Odronextamab is a hinge-stabilized, fully human immunoglobulin G4 (IgG4)-based CD20×CD3 bispecific antibody currently evaluated for the treatment of relapsed/refractory (R/R) B-Cell non-Hodgkin lymphoma (NHL). Preliminary studies have shown that in patients with R/R NHL, the use of odronextamab does not lead to the development of neurologic toxicity; however, it can lead to the development of cytokine release syndrome (CRS), a serious condition associated with the use of immunotherapy. In December 2020, the FDA placed a partial clinical hold and requested the drug developer, Regeneron Pharmaceuticals, to amend clinical protocols to reduce the incidence of CRS. The partial clinical hold was later lifted in May 2021. A phase I clinical study (NCT02290951) showed that in heavily pre-treated patients with B-cell non-Hodgkin lymphoma, odronextamab elicited a durable response with a manageable safety profile.
Background
Odronextamab is a hinge-stabilized, fully human immunoglobulin G4 (IgG4)-based CD20×CD3 bispecific antibody currently evaluated for the treatment of relapsed/refractory (R/R) B-Cell non-Hodgkin lymphoma (NHL). Preliminary studies have shown that in patients with R/R NHL, the use of odronextamab does not lead to the development of neurologic toxicity; however, it can lead to the development of cytokine release syndrome (CRS), a serious condition associated with the use of immunotherapy. In December 2020, the FDA placed a partial clinical hold and requested the drug developer, Regeneron Pharmaceuticals, to amend clinical protocols to reduce the incidence of CRS. The partial clinical hold was later lifted in May 2021. A phase I clinical study (NCT02290951) showed that in heavily pre-treated patients with B-cell non-Hodgkin lymphoma, odronextamab elicited a durable response with a manageable safety profile.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/03 | Phase 2 | Not yet recruiting | |||
2025/01/20 | Phase 2 | Recruiting | |||
2024/12/16 | Phase 1 | Recruiting | City of Hope Medical Center | ||
2024/01/30 | Phase 3 | Recruiting | |||
2023/11/28 | Phase 3 | Recruiting | |||
2023/10/24 | Phase 3 | Recruiting | |||
2023/10/19 | Phase 3 | Active, not recruiting | |||
2023/10/19 | Phase 3 | Recruiting | |||
2023/08/14 | Phase 2 | Recruiting | |||
2023/01/13 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||