Odronextamab FDA Approval Status
Last updated by Judith Stewart, BPharm on Oct 10, 2023.
FDA Approved: No
Generic name: odronextamab
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
Odronextamab is an investigational CD20xCD3 bispecific antibody in development for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL).
- FL and DLBCL are both subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing subtype, while DLBCL is a more aggressive form.
- Odronextamab is a bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
- A Biologics License Application (BLA) has been submitted to the FDA for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The target action date for the FDA decision is March 31, 2024.
- The FDA has granted odronextamab Orphan Drug Designation and Fast Track Designation for FL and DLBCL.
- Regeneron is also initiating a broad Phase 3 development program to investigate odronextamab in earlier lines of therapy and other B-NHLs.
Development timeline for odronextamab
Further information
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