Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Odronextamab multiple dose levels · 1 trial · 2 indications
Part A and B
Part A and B
Expansion Cohorts: • Diffuse large B-cell lymphoma (DLBCL) after failure of CAR-T therapy Part A
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | DLBCL post CAR-T |
| 1N Part B | EXPERIMENTAL | FL |
| 2N Part B | EXPERIMENTAL | DLBCL |
| Name | Type | Description |
|---|---|---|
| Odronextamab multiple dose levels | DRUG | Administered by intravenous (IV) infusion |
Key Inclusion Criteria: 1. Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate: * Part A (IV administration) B-NHL confirmed by National Ca...
Odronextamab is an investigational small molecule being studied for the treatment of Non-Hodgkin Lymphoma. It is currently in Phase 1 clinical development. The drug has been evaluated in a completed clinical trial that also included patients with Chronic Lymphocytic Leukemia.
Odronextamab is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting clinical research to evaluate the safety and tolerability of this investigational drug in patients with certain B-cell malignancies.
Odronextamab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received Priority Review designation from the FDA, indicating an expedited review process for its development.
Odronextamab has been studied in one completed clinical trial with the identifier NCT02290951. This Phase 1 study investigated the safety and tolerability of the drug in patients with CD20+ B-cell malignancies, including Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. The trial enrolled 200 participants across multiple countries.
Odronextamab is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has received Priority Review designation from the FDA, which is a status granted to drugs that may offer significant improvements in treatment, but it does not indicate approval.