Odronextamab FDA Approval Status
Last updated by Judith Stewart, BPharm on Dec 10, 2024.
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 was March 31, 2024, but the agency issued Complete Response Letters (CRLs) related to the enrollment status of the confirmatory trials. The CRLs (for R/R FL and R/R DLBCL) did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing.
- 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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